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 .
DETAILED ACTION
This is the first office action in response to the above identified patent application filed on 10/24/2025. Claims 1-20 are currently pending and being examined.
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 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.
Election/Restrictions
Claims 5-9 and 16-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/24/2025.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1 recites “said distal tip” in line 2. However, there is a lack of antecedent basis for this limitation. Examiner suggests reciting “said atraumatic distal tip”. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: Claim 1 recites “the longitudinal axis” in line 2. However, there is a lack of antecedent basis for this limitation. Examiner suggests reciting “a longitudinal axis”. Appropriate correction is required.
Claim 2 is objected to because of the following informalities: Claim 2 recites “said cannula distal tip” in line 3. However, there is a lack of antecedent basis for this limitation. Examiner suggests reciting “said blunt, atraumatic distal tip”. Appropriate correction is required.
Claim 3 is objected to because of the following informalities: Claim 3 recites “said bendable cannula distal tip sections” in line 2. However, there is a lack of antecedent basis for this limitation. Examiner suggests reciting “said at least three straight-cut sections”. Appropriate correction is required.
Claims 3 and 4 are objected to because of the following informalities: Claims 3 and 4 recites “said cannula distal tip” in lines 4 and 1 respectively. However, there is a lack of antecedent basis for this limitation. Examiner suggests reciting “said blunt, atraumatic distal tip”. Appropriate correction is required.
Claim 4 is objected to because of the following informalities: Claim 4 recite “said distal tip” in line 3. However, there is a lack of antecedent basis for this limitation. Examiner suggests reciting “said blunt, atraumatic distal tip”. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: Claim 10 recites “the longitudinal axis” in line 2. However, there is a lack of antecedent basis for this limitation. Examiner suggests reciting “a longitudinal axis”. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: Claim 10 recite “said distal tip” in lines 3 and 15. However, there is a lack of antecedent basis for this limitation. Examiner suggests reciting “said blunt, atraumatic distal tip”. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: Claim 10 recites many terms that lack antecedent basis listed below;
“the proximal end” in line 5, suggested to read “a proximal end”
“the hollow passageway” in line 6, suggested to read “a hollow passageway”
“the cannula body” in line 6, suggested to read “a cannula body”
“the user” in line 10, suggested to read “a user”
“the outer body” in line 11, suggested to read “a outer body”
“the front cover” in line 12, suggested to read “a front cover”
“the device” in line 12, suggested to read “the insertion device”
“the top cover” in line 13, suggested to read “a top cover”
“the cannula-holder grip” in line 21, is suggested to read “a cannula-holder grip”
Appropriate correction is required
Claims 11 and 12 are objected to because of the following abnormalities: Claim 11 and 12 recite “the device” in line 2. However, there is a lack of antecedent basis for this limitation. Examiner suggests reciting “the insertion device”. Appropriate correction is required.
Claim 13 is objected to because of the following informalities: Claim 13 recites “said cannula distal tip sections” in line 2. However, there is a lack of antecedent basis for this limitation. Examiner suggests reciting “at least three straight-cut sections”. Appropriate correction is required.
Claim 13 is objected to because of the following informalities: Claim 13 recites “said obturator distal tip” in line 2. However, there is a lack of antecedent basis for this limitation. Examiner suggests reciting “an obturator distal tip”. Appropriate correction is required.
Claim 13 is objected to because of the following informalities: Claim 13 recites “said cannula distal tip aperture” in line 3. However, there is a lack of antecedent basis for this limitation. Examiner suggests reciting “a cannula distal tip aperture”. Appropriate correction is required.
Claim 15 is objected to because of the following informalities: Claim 15 recites “the flat edge” in line 2. However, there is a lack of antecedent basis for this limitation. Examiner suggests reciting “a flat edge”. Appropriate correction is required.
Examiner has attempted to find every antecedent issue, however due to the complexity of the claims examiner suggests reviewing the claims thoroughly.
Claim Rejections - 35 USC § 102
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 1, 2, and 4 are rejected under 35 U.S.C. 102(a) as being anticipated by Mellejor (USPAP 2014/0378948).
In reference to independent claim 1, Mellejor discloses a cannula (110, fig 4-6) with a blunt, atraumatic distal tip (122, fig 5) curving inward in the direction of the longitudinal axis of said cannula (fig 5 shows a closeup of the end which is blunt, atraumatic, and inward curving), wherein said distal tip has at least three straight-cut sections along the longitudinal axis (fig 11 shows how it has 4 sections), resulting in a corresponding number of distal inward-curving tip sections (para 0030 discloses “The at least one tooth 132 extends inwardly from the tongues 126 and can serve to prevent the medicament from being prematurely expelled by providing an additional barrier that must be overcome during expulsion. The number of teeth 132 can vary depending on the specific shape and size of the medicament and the support section 122. In some embodiments, each tongue 126 has at least one tooth 132.”).
In reference to dependent claim 2, Mellejor discloses the cannula of claim 1 wherein at least three straight-cut sections are bendable (the sections 126 flex to allow the implant 190), allowing an obturator (150), at least one pellet, and/or at least one implantable device (190) to be pushed through the inside of said cannula (inside of the end of 110) and egress from said cannula distal tip (fig 13b shows the implant 190 leaving the end of the cannula).
In reference to dependent claim 4, Mellejor discloses the cannula of claim 1 wherein at least one section of said cannula distal tip (122, fig 5) is bendable when an obturator (150), at least one pellet, and/or at least one implantable device (190) is pushed through said distal tip sections (126), and at least one section returns to its original shape when said obturator, pellet, and/or device (190) is no longer prying open said cannula distal tip sections (para 0030 discloses “The at least one tooth 132 extends inwardly from the tongues 126 and can serve to prevent the medicament from being prematurely expelled by providing an additional barrier that must be overcome during expulsion. The number of teeth 132 can vary depending on the specific shape and size of the medicament and the support section 122. In some embodiments, each tongue 126 has at least one tooth 132.” The “overcoming” indicates the device 190 bends or pry’s the sections 126 apart to push the device thru.).
Claim Rejections - 35 USC § 103
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 3 are rejected under 35 U.S.C. 103 as being unpatentable over Mellejor (USPAP 2014/0378948) in view of Wach (USPAP 2013/0345634).
In reference to dependent claim 3, Mellejor discloses the cannula of claim 1 wherein at least three straight-cut sections are bendable (para 0030 discloses “The at least one tooth 132 extends inwardly from the tongues 126 and can serve to prevent the medicament from being prematurely expelled by providing an additional barrier that must be overcome during expulsion. The number of teeth 132 can vary depending on the specific shape and size of the medicament and the support section 122. In some embodiments, each tongue 126 has at least one tooth 132.” The “overcoming” indicates the device 190 bends or pry’s the sections 126 apart to push the device thru.), allowing an obturator (150) to be pushed through the inside of said cannula (110) and egress from said cannula distal tip (fig 13b shows the obturator extending just past the edge of the tip), however
Mellejor does not teach an obturator with grooves in said distal tip that are shaped to correspond to said bendable cannula distal tip sections.
Wach, a similar delivery device, teaches an obturator with grooves (grooves that 3170 fit into in the end 3840, fig 54-57) in said distal tip that are shaped to correspond to said bendable cannula distal tip sections (tip sections 3170 fit into the grooves of 3840).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the grooves in the end of the obturator as taught in Wach in the obturator of Mellejor to “align[[ing]] the curved surfaces 3842 with each of the extending members 3170 so that the extending members 3170 pass over the curved surfaces 3842 when the retractable member 3840 is retracted” para 0185, Wach.
Claims 10, 14, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Benning (EP 531036) in view of Mellejor (USPAP 2014/0378948) further in view of Fischer (USPN 4,004,565).
In reference to independent claim 10, Benning disclose an insertion device (1, fig 1) comprising:
a cannula (3);
a cannula-holder (2), attached to proximal end of said cannula (3), with an aperture perpendicular to the cannula’s longitudinal axis that is large enough for the ingress of a single pellet or insertable implant (14) and which aligns with the hollow passageway inside said cannula body (seen in fig 2a-e), and a grip (10, fig 2) attached through the top cover of said device which allows the user to move the cannula-holder (2) along the longitudinal axis of the cannula within the outer body (pulling back on 10 allows the cannula holder to move along its longitudinal axis and trip 15 with 11); as well as an aperture (aperture inside 13) that allows the cannula-holder grip (“control handle” 15) to traverse longitudinally within the outer body (15 can move the holder 3 thru the cannula-holder);
a spring mechanism (4, fig 2) located between the cannula-holder (2) and the front cover of the device (left side of the housing 13);
a catch-release mechanism (12), allowing the cannula-holder and the top cover of the device to be engaged when the spring mechanism (4) is compressed (seen in fig 2b);
an outer body (13), comprising a housing (13) and a front cover (left side of 13, fig 1) with an aperture large enough for the distal tip of the cannula to egress (aperture that holds 3, fig 1);
a back cover (back portion of 13 that is pierced by 9) with an aperture large enough for an obturator (9) with a releasable locking mechanism (8) that engages with the back cover to ingress and egress (8 locks 10 in the rear and is engaged during ingress and egress, seen in fig 2a-e);
an obturator (9), with a releasable locking mechanism (8) that interacts with the back cover (right side of 13), and a grip (10) on the proximal end of said obturator (9); however
Benning does not teach a cannula with a blunt, atraumatic distal tip curving inward in the direction of the longitudinal axis of said cannula wherein said distal tip has at least three straight-cut sections along the longitudinal axis, resulting in distal inward-curving tip sections, and an aperture on the proximal end large enough for an obturator to travel along the longitudinal axis throughout the hollow passageway inside the cannula body;
a top cover with an aperture located between a proximal clip and a distal clip that are used to releasably slide a flat-edged packaging strip of pellets or insertable implants, as well as an aperture that allows the cannula-holder grip to traverse longitudinally within the outer body;
a packaging strip with flat edges containing one or more pellets and/or insertable implants adjacent to each other that can be removably inserted into at least two corresponding adjustable clips located on opposite sides of an aperture in the top cover of said insertion device.
Mellejor, a similar implant insertion device, teaches a cannula (110, fig 4-6) with a blunt, atraumatic distal tip curving inward in the direction of the longitudinal axis of said cannula (fig 5 shows a closeup of the end which is blunt, atraumatic, and inward curving) wherein said distal tip has at least three straight-cut sections along the longitudinal axis (fig 11 shows how it has 4 sections), resulting in distal inward-curving tip sections (para 0030 discloses “The at least one tooth 132 extends inwardly from the tongues 126 and can serve to prevent the medicament from being prematurely expelled by providing an additional barrier that must be overcome during expulsion. The number of teeth 132 can vary depending on the specific shape and size of the medicament and the support section 122. In some embodiments, each tongue 126 has at least one tooth 132.”), and an aperture (118) on the proximal end large enough for an obturator (150) to travel along the longitudinal axis throughout the hollow passageway inside the cannula body (see figs 12);
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the cannula design of Mellejor in the implant device of Benning “to prevent the medicament [or any implant] from being prematurely expelled by providing an additional barrier that must be overcome during expulsion” para 0030, Mellejor.
Mellejor does not teach a top cover with an aperture located between a proximal clip and a distal clip that are used to releasably slide a flat-edged packaging strip of pellets or insertable implants, as well as an aperture that allows the cannula-holder grip to traverse longitudinally within the outer body;
a packaging strip with flat edges containing one or more pellets and/or insertable implants adjacent to each other that can be removably inserted into at least two corresponding adjustable clips located on opposite sides of an aperture in the top cover of said insertion device.
Fischer, a similar implant device, teaches a top cover (top cover of 10, fig 1) with an aperture (18) located between a proximal clip (left side of 18, fig 1) and a distal clip (right side of fig 1) that are used to releasably slide a flat-edged packaging strip (15) of pellets or insertable implants (22),
a packaging strip (15) with flat edges (flat edges formed by 16 and 25) containing one or more pellets and/or insertable implants (22) adjacent to each other that can be removably inserted into at least two corresponding adjustable clips (clips on either side of 18) located on opposite sides of an aperture (18) in the top cover of said insertion device (top of 10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the clip and clip interface as taught by Fischer in the insertion device as taught by Benning in view of Mellejor because it “protects each projectile within a cavity or chamber by a rupturable seal from impurities, providing a hygienically packaged projectile with the biologically active material in the dry form preventing contamination, or loss of potency, i.e. strength” (col 1, lines 32-36) and “to permit individual injection and then removal of the clip without disturbing the hygienic packaging of the remaining implant projectiles” col 1, lines 37-40, Fischer.
In reference to dependent claim 14, Benning in view of Mellejor and Fischer discloses the insertion device of Claim 10,
Benning and Fischer are silent to at least one finger grip for the user on the outer body.
Mellejor, a similar implant insertion device, teaches at least one finger grip for the user on the outer body (para 0034 discloses “The corrugations 134 can be any suitable pattern or configuration and provide a textured area for a user to grip the assembly 100.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the grip as taught by Mellejor in the device of Benning in view of Mellejor and Fischer “to prevent slippage of the elongate tube between the user's fingers” para 0034, Mellejor.
In reference to dependent claim 15, Benning in view of Mellejor and Fischer discloses the insertion device of Claim 10, Fischer further discloses a device further comprising at least one raised area (25) on the flat edge of the blister packaging strip (15) that integrates with a corresponding gap in at least one top cover aperture clip (15 inserts into the aperture 18 that is integrated into the device, both the flat edges of 16 and 25 integrate with 18), allowing the packaged pellet/implant to align over the top cover aperture (seen in fig 1).
Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Benning (EP 531036) in view of Mellejor (USPAP 2014/0378948) further in view of Fischer (USPN 4,004,565) further in view of Bertagnoli (USPN 7,763,024).
In reference to dependent claim 11, Benning in view of Mellejor and Fischer discloses the insertion device of Claim 10, however
Benning, Mellejor, and Fischer do not teach an attached lancet located on the top cover of the device.
Bertagnoli, a similar medical device for inserting/removing an implant from the human body, teaches an attached lancet (blade portion 54, fig 1) located on the top cover (52) of the device (54 is on the top cover of the device).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the lancet as taught in Bertagnoli in the device of Benning in view of Mellejor and Fischer “ to provide new and improved methods for preparing an intervertebral space for receiving an artificial disc implant” col 3, lines 28-30, Bertagnoli.
In reference to dependent claim 12, Benning in view of Mellejor, Fischer, and Garcia discloses the insertion device of Claim 10, however
Benning, Mellejor, and Fischer do not teach an attached lancet located on the top cover of the device.
Bertagnoli, a similar medical device for inserting/removing an implant from the human body, teaches an attached lancet (blade portion 54, fig 1) located on the top cover of the device (54 is on the top cover of the device).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the lancet as taught in Bertagnoli in the device of Benning in view of Mellejor and Fischer “ to provide new and improved methods for preparing an intervertebral space for receiving an artificial disc implant” col 3, lines 28-30, Bertagnoli.
Bertagnoli, Mellejor, and Fischer do not teach an adjustable cover removably attached with a safety locking mechanism.
Benning has an adjustable cover (body of 14) removably attached with a safety locking mechanism (locking mechanism 12 allows the cannula 3 to be completely covered).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a cover as taught in Benning in the device of Benning in view of Mellejor, Fischer, and Bertagnoli to provide a safer device where the cutting device is protected.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Benning (EP 531036) in view of Mellejor (USPAP 2014/0378948) further in view of Fischer (USPN 4,004,565) further in view of Wach (USPAP 2013/0345634).
In reference to dependent claim 13, Benning in view of Mellejor and Fischer discloses the insertion device of Claim 10, allowing an obturator (150) to be pushed through the inside of said cannula (110) and egress from said cannula distal tip (fig 13b shows the obturator extending just past the edge of the tip), however
Benning, Mellejor, and Fischer do not teach an obturator with grooves in said distal tip that are shaped to correspond to said bendable cannula distal tip sections.
Wach, a similar delivery device, teaches an obturator with grooves (grooves that 3170 fit into in the end 3840, fig 54-57) in said distal tip that are shaped to correspond to said bendable cannula distal tip sections (tip sections 3170 fit into the grooves of 3840).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the grooves in the end of the obturator as taught in Wach in the obturator of Benning in view of Mellejor and Fischer to “align[[ing]] the curved surfaces 3842 with each of the extending members 3170 so that the extending members 3170 pass over the curved surfaces 3842 when the retractable member 3840 is retracted” para 0185, Wach.
Conclusion
Examiner has cited particular columns and line and/or paragraph numbers in the references applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings of the art and are applied to specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested from the applicant in preparing responses, to fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the Examiner.
The examiner requests, in response to this Office action, support be shown for language added to any original claims on amendment and any new claims. That is, indicate support for newly added claim language by specifically pointing to page(s) and line no(s) in the specification and/or drawing figure(s). This will assist the examiner in prosecuting the application.
When responding to this office action, Applicant is advised to clearly point out the patentable novelty which he or she thinks the claims present, in view of the state of the art disclosed by the references cited or the objections made. He or she must also show how the amendments avoid such references or objections See 37 CFR 1.111(c).
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Solomon (USPAP 2010/0022952) discloses a bioinjection device.
Yoon (USPN 5,752,970) discloses an end valve.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHARLES W NICHOLS whose telephone number is (571)272-6492. The examiner can normally be reached Monday-Friday 8am-5pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.W.N/Examiner, Art Unit 3783
/WESLEY G HARRIS/Examiner, Art Unit 3783