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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/16/2026 has been entered.
Response to Arguments
Applicant's arguments filed 2/09/2026 have been fully considered as noted in the advisory action m ailed 2/13/2026.
Applicant argues that the previously cited prior art fails to teach the two dimples spaced 180 apart radially and 2m to 10 mm apart axially. This argument is convincing. However, upon further consideration in light of the amendments to the claims a new rejection is made in view of Lowery et al (US 6,949,064) which teaches circumferentially and axially spaced apart crimps. Lowery does not teach the specifically claimed orientations, however, applicant has not provided any criticality to these limitations and Lowery teaches that the particular location of the crimps may be determined through routine experimentation.
Applicant argues that Fischer does not indicate any deficiencies in the cannula guard that would motivate a person to seek enhancements and therefore there is no rationale for consulting Van Der Graaf for alternative design approaches to the cover or cannula guard. This arguments is not convincing. Per MPEP 2144(I), rationale for combining a reference may be com common knowledge in the art. In the art of medical needles, providing guards on a needle is very well known to provide protection from accidental sticks which can transmit infection.
Applicant argues that Gall pertains to a means for dispensing substances rather than an injectable system and therefore a person of ordinary skill in the art would lack motivation to consult Gall. This argument is not convincing. The claimed invention and Gall are both in the same field of endeavor, namely the delivery of solid substances from a syringe-like device.
Claim Objections
Claim 15 is objected to because of the following informalities: claim 15 recites “dalling” instead of “falling”. Appropriate correction is required.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 3-5, 7, 8, 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fischer et al (WO 2017/019631 A1) in view of Lowery et al (US 6,949,064) in view of Van Der Graaf et al (US 8,888,745) in view of Gall et al (US 4,871,094) in view of Smith et al (US 2016/0354115).
Regarding claim 1, Fischer discloses an applicator for inserting an implant under a skin of a human or animal (abstract; Figs. 3A, 3B), comprising: a housing 301; a needle 303 extending distally from the housing, the needle being configured to receive the implant 307; a pushrod 306 within the housing extending within the needle; a needle penetration guide 304 extending distally from the housing along at least a portion of a length of the needle (figs. 3A, 3B; page 8, para. 0043); and an actuator 310 provided on the housing configured to be actuated by a user to release the implant from the needle (figs. 3A, 3B; page 8, para. 0043); wherein the needle is crimped such that the crimps help to retain and secure the implant inside the needle before insertion of the applicator, thereby preventing the implant from accidently falling out of the needle (Figs. 6A, 6B; page 9, para. 0047: inwardly protruding area is interpreted to be a crimp).
Claim 1 differs from Fischer in calling for the needle to be crimped such that two dimples spaced apart 180 degrees radially and 2mm to 10mm apart axially. Applicant has not provided criticality to this particular orientation of the dimples as the claimed orientation is one example of many given by applicant for suitable dimple orientations (specification page 13). Lowery teaches a needle for holding a solid implant, wherein the needle includes at least two dimples 100, 102 spaced radially around the needle and space axially from each other (figs. 4B, 4C), the particular location and orientation of the crimps may be determined through routine experimentation to achieve the desired performance of the device (col. 11,m lines 32-51). 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 crimps of Fischer to include two dimples spaced radially and axially from each other as taught by Lowery to provide the desired holding effect to the implant located therein, the particular orientation and location of the dimples being a matter of routine experimentation.
Claim 1 differs from Fischer in calling for a protective cover configured to engage the housing to cover the needle and the needle penetration guide. Van Der Graaf teaches an applicator for inserting an implant under the skin, the applicator including a protective cover 7 that engages the housing to cover the needle and insertion guide (figs. 1, 2; col. 2, line 55). Protective covers are known in the art to prevent accidental sticks and maintain the cleanliness of the needle and skin contacting portions of the device prior to use. 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 of Fischer to include a protective cover that engages the housing to cover the needle and penetration guide as taught by Van Der Graaf to ensure that the needle and skin contacting portions remain clean to prevent infection prior to use and to prevent accidental sticks.
Claim 1 further differs from the teachings above in calling for the needle to comprises a slot provided between a proximal end and a distal end of the needle configured for loading of the implant into the needle through the slot. Gall teaches an applicator for inserting an implant under the skin wherein the needle includes a slot allowing for the implant to be loaded into the needle (Fig. 1A; col. 3, lines 57-59; col. 4, lines 45-48) thereby increasing ease of use of the device as the desired implant can be loaded into the needle without accessing the sharp distal end. 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 needle of Fischer to include a slot to allow the implant to be loaded into the needle as taught by Gall to allow the implant to be loaded into the needle as needed without the user having access the sharp distal end of the needle thereby increasing ease of use and safety of the device.
Claim 1 differs from the teachings above in calling for the needle penetration guide to be transparent. Smith teaches an applicator for inserting an implant under the skin, the applicator including a needle penetration guide, the needle penetration guide being transparent to allow visualization of the needle into the skin while preventing the user from palpating the area during implantation thereby allowing successful implantation (page 10, para. 0114; Fig. 5A). 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 needle penetration guide of Fischer to be transparent as taught by Smith to allow the user to view the needle entering the skin while preventing palpation of the area thereby ensuring successful implantation.
Regarding claim 3, Gall further teaches that the slot is configure for loading the implant at an angle perpendicular to a longitudinal axis of the needle (fig. 1A: the implant is moved perpendicularly into the slot). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that this feature is included in the combination described above with regard to claim 1 to allow the implant to be loaded into the needle without having to push the implant parallel to the longitudinal axis through the sharp tip of the needle thereby increasing safety of loading the implant into the needle.
Regarding claim 4, Gall further teaches that the slot is greater in length than the implant (fig. 1A) so that the implant can be easily received in the slot without damaging the implant. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include in the combination described above with regard to claim 1, a slot having a length greater than the length of the implant as taught by Gall so that the implant can be easily loaded into the needle without damaging the implant.
Regarding claim 5, Fischer discloses that the actuator is configured to be actuated to retract the needle into the housing (Fig. 3B; page 8, para. 0044).
Regarding claim 7, Fischer discloses that the needle penetration guide 304 is coupled to the housing and extends distally from the housing (fig. 3A).
Regarding claim 8, Fischer discloses that the needle penetration guide extends from the housing substantially parallel to the needle (fig. 3A).
Claim 18 calls for the penetration guide to deflect not more than 1 mm on application of 1 Newton of forces at the end of the straight portion. Applicant has not provided criticality to this limitation. Fischer discloses that the purpose of the penetration guide portion is to guide the needle insertion to the desired angle (page 5, para. 0036). This purpose can only be achieved if the guide does not deflect out of the predetermined configuration. 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 penetration guide of Fischer so that it is rigid enough that application of 1N of force does not deflect the end of the guide more than 1mm because applicant has not provided criticality to this limitation and the purpose of the guide of Fischer is to be rigid so that the angle of penetration of the needle is fixed to the desired angle.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fischer in view of Lowery in view of Van Der Graaf in view of Gall in view of Smith as applied to claim 1 above, and further in view of Beelen et al (US 2009/0012463).
Claim 6 differs from Fischer in calling for the housing to include a left side housing, a right side housing, and a bottom housing. Beelen teaches an applicator for inserting an implant under the skin, the applicator including a housing having a left side 5, a right side 6, and a bottom 9 (fig. 3; page 2, para. 0026). This configuration allows for easy manufacturing and assembly of the device. 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 housing of Fischer to include a left side, a right side, and a bottom portions as taught by Beelen to allow for easy manufacture and assembly of the housing with the internal components.
Claim(s) 15, 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fischer in view of Lowery in view of Smith in view of Van Der Graaf.
Regarding claim 15, Fischer discloses an applicator for inserting an implant under a skin of a human or animal (abstract), comprising: a housing 301; a needle 303 configured to receive the implant 307 and deliver the implant under the skin, wherein the needle comprises a first position (fig. 3A) where the needle extends distally from the housing and a second position (fig. 3B) where the needle is retracted into the housing, wherein the needle is crimped to retain and secure the implant inside the needle before insertion of the application, thereby preventing the implant from accidentally fall out of the needle (Figs. 6A, 6B; page 9, para. 0047: inwardly protruding area is interpreted to be a crimp) wherein the needle is configured to allow the implant to remain under the skin when the needle moves from the first position to the second position (page 8, para. 0044); a needle penetration guide 304 coupled to a portion of the housing and extending distally from the housing (fig. 3A), wherein the needle penetration guide is configured to guide the needle while it is inserted under the skin (page 5, para. 0036), wherein the needle penetration guide comprises: a first portion comprising a solid flat surface on a needle facing side of the penetration guide (fig. 3A: bottom surface of 304 extending along the length of the needle), wherein the first portion is connected to the housing and extends distally from the housing and substantially parallel to the needle (fig. 3A), a second portion positioned distal to the first portion, wherein the second portion comprises a solid curved surface curved away from the needle (fig. 3A: distal tip of the guide is curved away from the needle), and an actuator 310 configured to move the needle form the first position to the second position (figs. 3A, 3B).
Claim 15 differs from Fischer in calling for the needle to be crimped such that two dimples spaced apart 180 degrees radially and 2mm to 10mm apart axially. Applicant has not provided criticality to this particular orientation of the dimples as the claimed orientation is one example of many given by applicant for suitable dimple orientations (specification page 13). Lowery teaches a needle for holding a solid implant, wherein the needle includes at least two dimples 100, 102 spaced radially around the needle and space axially from each other (figs. 4B, 4C), the particular location and orientation of the crimps may be determined through routine experimentation to achieve the desired performance of the device (col. 11,m lines 32-51). 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 crimps of Fischer to include two dimples spaced radially and axially from each other as taught by Lowery to provide the desired holding effect to the implant located therein, the particular orientation and location of the dimples being a matter of routine experimentation.
Claim 15 differs from the teachings above in calling for the needle penetration guide to be transparent. Smith teaches an applicator for inserting an implant under the skin, the applicator including a needle penetration guide, the needle penetration guide being transparent to allow visualization of the needle into the skin while preventing the user from palpating the area during implantation thereby allowing successful implantation (page 10, para. 0114; Fig. 5A). 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 needle penetration guide of Fischer to be transparent as taught by Smith to allow the user to view the needle entering the skin while preventing palpation of the area thereby ensuring successful implantation.
Claim 15 further differs from Fischer in calling for a protective cover configured to be releasably engaged and disengaged to the housing to cover the needle and the needle penetration guide when the applicator is not in use. Van Der Graaf teaches an applicator for inserting an implant under the skin, the applicator including a protective cover 7 that engages the housing to cover the needle and insertion guide (figs. 1, 2; col. 2, line 55). Protective covers are known in the art to prevent accidental sticks and maintain the cleanliness of the needle and skin contacting portions of the device prior to use. 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 of Fischer to include a protective cover that engages the housing to cover the needle and penetration guide as taught by Van Der Graaf to ensure that the needle and skin contacting portions remain clean to prevent infection prior to use and to prevent accidental sticks.
Regarding claim 17, Smith further teaches that the needle penetration guide comprises ribs 140 extending perpendicularly and upwardly form the sides of the solid flat surface to provide stability and rigidity to the guide while allowing the guide to include the transparent material (fig. 2A; page 7, para. 0098). 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 needle penetration guide of Fischer in view of Smith described above to include ribs as taught by Smith to provide rigidity and stability to the guide.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fischer in view of Lowery in view of Van Der Graaf in view of Gall as applied to claim 1 above, and further in view of Morlok et al (US 2021/0138217).
Claim 19 calls a housing guide front, housing guide rear, needle guiding means front, needle guiding means rear, and the needle holder, wherein the needle guiding means front and the needle guiding means rear engages the housing guide front and housing guide rear, respectively to keep the needle holder in place during insertion while allowing the needle holder to slide inside the housing when actuated by the actuator, wherein upon release of the implant from the needle, the needle guiding means front disengages with the housing guide front to secure the needle within the housing. Fischer discloses that the cannula retractor mechanism can be any desired motion transfer mechanism including a spring-loaded system (page 8, para. 0043), but fails to disclose the details of such system. Morlok teaches an applicator for depositing an implant under the skin wherein the cannula retraction mechanism includes a spring loaded system. Morlok teaches a housing guide front, housing guide rear (fig. 2: housing guide 26 front and read), needle guiding means front, needle guiding means rear (needle guiding means 22, front and rear), and the needle holder, wherein the needle guiding means front and the needle guiding means rear engages the housing guide front and housing guide rear, respectively to keep the needle holder in place during insertion while allowing the needle holder to slide inside the housing when actuated by the actuator (fig. 2), wherein upon release of the implant from the needle, the needle guiding means front disengages with the housing guide front to secure the needle within the housing (fig. 5). This allows spring loaded retraction of the needle thereby ensuring that the needle is completely retracted to a locked position thereby preventing accidental sticks after use. 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 cannula retraction mechanism of Fischer to be of the type described by Morlok as described above because doing so allows the needle to be retracted by a spring thereby reducing user error and increasing the safety of the device.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA A BOUCHELLE whose telephone number is (571)272-2125. The examiner can normally be reached Mon-Fri 8:00-5:00 CST.
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LAURA A. BOUCHELLE
Primary Examiner
Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783