DETAILED ACTION
Claims 4, 11, 18, 28, 31-32, 48, 51, and 55 are amended. A complete action on the merits of pending claims 1-2, 4, 6, 11-12, 14, 17-19, 21, 23-24, 26, 28, 31-32, 36, 41-42, 45, 47-48, 51 and 55 appears below.
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 .
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Response to Amendment
Acknowledgment is made to Applicant’s amendments filed on 11/10/2025 which are entered. With regards to the drawing and specification objections documented in the Non-Final Office Action sent on 08/13/2025 all are overcome through Applicant’s amendments and are withdrawn. With regards to the claim objections documented in the Non-Final Office Action sent on 08/13/2025, all are overcome through Applicant’s amendments and are withdrawn, except for one objection, specifically the objection of claim 32, where in the amendments filed on 11/10/2025, Applicant has amended the wrong term/limitation (See updated objection below). Lastly, with regards to the 35 USC 112(b) rejections documented in the Non-Final Office Action sent on 08/13/2025, all are overcome through Applicant’s amendments and are withdrawn.
Claim Objections
Claim 32 is objected to because of the following informalities:
Claim 32 should be amended to the following, “The tissue orientation clip delivery system of claim 28, wherein the cartridge lumen includes a track along a length of the cartridge.” The limitation “cartridge lumen” was introduced in claim 28 which claim 32 depends upon, and therefore should be preceded by “the” since it has clear antecedent basis. However, “length of the cartridge” is a new limitation/feature introduced for the first time in claim 32 therefore should be introduced with “a” rather than “the”.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
Claim(s) 1-2, 4, 6, 11, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jackson (US Patent No. 5381989 A), in view of Phillips (US Patent No. 8594768 B2).
Regarding claim 1, Jackson discloses, clamps with an adjustment mechanism for adjusting the bias of the spring. Jackson teaches, a tissue orientation clip (Figure 1, adjustable spring clamp (10); Col. 2, line 44-51; the adjustable spring clamp (10) is for gripping, “tissue orientation” is a functional preamble, capable of marking via attachment) comprising:
a first clip jaw (Figure 1, first gripping member (18); Col. 2, line 52-57) including a first lateral handle (Figure 1, first lever arm (28)) at a proximal end of the first clip jaw (Figure 1; Col. 2, line 54-57), the first lateral handle defining a first spring arm receiving slot therein (Col. 2, line 61-Col. 3, line 6, “The clamp 12 further includes a force applying means in the form of a helically coiled spring 14 includes a coiled portion 38 forming a tube 44 and first and second end extensions 40 and 42 projecting from the tube 44 … engage the lever arms 28 and 30.”; Figure 1 partially cut away shows extension (40) in arm (28), indicating slot/groove for receipt);
a second clip jaw (Figure 1, second gripping member (20); Col. 2, line 54-57), a second lateral handle (Figure 1, second lever arm (30)) at a proximal end of the second clip jaw (Figure 1; Col. 2, line 54-57), the second lateral handle defining a second spring arm receiving slot therein (Col. 2, line 61-Col. 3, line 6, “The clamp 12 further includes a force applying means in the form of a helically coiled spring 14 includes a coiled portion 38 forming a tube 44 and first and second end extensions 40 and 42 projecting from the tube 44 … engage the lever arms 28 and 30.”; Figures 2-3 shows extension (42) in arm (30), indicating slot/groove for receipt); and
a spring (Figure 1, helically coiled spring (14)) including a first spring arm (Figure 1, first end extension (40)) received in the first spring arm receiving slot and a second spring arm (Figure 1, second end extension (42)) received within the second spring arm receiving slot (Figures 1-3; Col. 2, line 61-Col. 3, line 6).
Jackson does not explicitly teach teeth on jaws.
Phillips discloses, a tissue marking clip. Phillips teaches, a tissue orientation clip (Figure 12, clip (230); Col. 8, line 22-24) with jaws having teeth at distal ends (Figure 12, teeth (270 & 275); Col. 8, line 43-46).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Jackson’s jaws with Phillips’s teeth, as both references and the claimed invention are directed to clips. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jackson’s jaws with Phillips’s teeth, as such a modification would have been predictable, namely, to improve secure tissue grip without slippage, as both are for holding specimens (Col. 8, line 50-55 of Phillips, “… teeth 270, 275 cooperate to produce a slight overbite 282 … improves the grip …”).
Regarding claim 2, Jackson further teaches, wherein the spring biases the tissue orientation clip in a closed position (Figure 1, shows closed bias; Col. 3, line 6-9, “The tension in the spring 14 biases the lever arms 28 and 30 to move apart, thereby urging the jaws 24 and 26 toward each other and the gripping position”).
Regarding claim 4, Jackson further teaches, wherein a protrusion (Figure 1, bracket (34) (or the portion of the pivot pin fixed/aligned with the second gripping member (20)/second lever arm (30) brackets) that extends into the aligned aperture; Col. 2, line 57-59) of the second clip jaw (second gripping member (20)) is rotatably received in a protrusion receiving hole (Figure 1, pivot pin receiving aperture (36); Col. 2, line 57-61) in the first clip jaw (first gripping member (18)) (This overlapping bracket-and-pin arrangement is structurally equivalent to the claimed “protrusion of the second clip jaw rotatably received in a protrusion receiving hole in the first clip jaw”).
Regarding claim 6, Jackson teaches, the tissue orientation clip according to claim 1 (See above rejection of claim 1).
Jackson fails to teach, further comprising indicia indicating an orientation of a tissue specimen.
Phillips teaches, further comprising indicia (Figure 12 or Figure 15, indicator (285)/indicia (360); Col. 9, line 15-16 and line 57-60) indicating an orientation of a tissue specimen (Col. 9, line 15-20, “… the indicator 285 includes a number of balls 290 formed as part of the tail 245. The balls 290 are substantially opaque in the X-ray region of the electromagnetic spectrum. As such, the balls 290 appear white on an X-ray. In this construction, the number of balls 290 on the tail 245 indicates orientation.”).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Jackson’s adjustable spring clamp by adding the radiopaque indicia (e.g., numbered/opaque balls or markers on a tail/extension portion) as taught by Phillips, as both references and the claimed invention are directed to clips. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jackson’s adjustable spring clamp by adding the radiopaque indicia (e.g., numbered/opaque balls or markers on a tail/extension portion) as taught by Phillips, as such a modification would have been predictable, namely, to allow radiographic (X-ray) identification of the clip’s orientation when attached to an excised tissue (Col. 8, line 22-24 of Phillips).
Regarding claim 11, Jackson in view of Phillips teach the claimed invention except for, “the clip is less than 3.5 cm in length and less than 3.5 cm in width.” It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the clamp of Jackson to have a length and width less than 3.5 cm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involve only routine skill in the art. Jackson already teaches a compact, hand-held adjustable spring clamp suitable for holding small parts (Col. 1, line 15-18). Phillips further provides motivation to optimize the clip size downward for small tissue specimens (<20 cm3) in minimally invasive procedures, where larger clips are unsuitable and must pass through 8-12 mm trocars (Col. 1, line 25-45 and Col. 3, line 58-63). Overall clip dimensions are a result-effective variable routinely optimized in the surgical clip art to achieve secure attachment to small specimens without damage or interference with trocar passage. The claimed size range (<3.5cm length and width) therefore represents nothing more than routine optimization of a parameter already suggested by the prior art. In re Aller.
Regarding claim 19, Jackson teaches, the tissue orientation clip according to claim 1 (See above rejection of claim 1).
Jackson does not explicitly teach, wherein the clip is made of a gamma stable plastic.
Phillips teaches, wherein the clip is made of a gamma stable plastic (Col. 10, line 56-65, “In these constructions the actuator portion 240, the jaw portion 235, and the tail 245 can be made from one material in a single injection molding step. Alternatively, two different materials could be used with the actuator portion 240 and the jaw portion 235 being made from a material that is translucent in the X-ray region of the electromagnetic spectrum, and the tail 245 being made from a more opaque material. In these constructions, a co-molding or two step injection molding process may be employed.” Plastic materials (e.g., polycarbonate, ABS, PETG) suitable for gamma sterilization are standard in single-use surgical clips).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to construct the clip of Jackson from gamma stable plastic, as taught by Phillips, as both references and the claimed invention are directed to clips. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to construct the clip of Jackson from gamma stable plastic, as taught by Phillips, as such a modification would have been predictable, namely, enable cost effective injection molding, single-use disposability, and reliable gamma ray sterilization without material degradation, which is conventional for surgical marking clips. This modification is no more than the predictable selection of known injection-moldable, gamma stable plastic in a spring biased clip (Jackson/Phillips) to facilitate manufacturing and sterilization for tissue orientation use, yielding predictable results (biocompatible, sterilizable device) with no unexpected technical effect.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jackson, in view of Phillips, and further in view of Oh (US Patent No. 4834096A).
Regarding claim 12, Jackson teaches, the first clip jaw (first gripping member (18)) and the second clip jaw (second gripping member (20)).
Jackson fails to teach, wherein the first clip jaw or the second clip jaw includes two or more posts extending perpendicularly from said first clip jaw or said second clip jaw.
Phillips teaches, aspects of the tissue orientation clip according to claim 1 (See above rejection of claim 1).
Oh discloses, surgical clips and clip appliers. Oh teaches, wherein the first clip jaw or the second clip jaw includes two or more posts extending perpendicularly from said first clip jaw or said second clip jaw (Figure 1 shows bosses (72 & 74) as two cylindrical posts protruding perpendicularly from the sides of the second clip jaw/leg (14) in opposite directions; Col. 5, line 40-42, “Leg member 14 includes a pair of cylindrical bosses 72 and 74 located at the tip 46 on opposite sides of the leg member 14 and extending laterally away therefrom”; Col. 5, line 47-49, “… bosses 72 and 74 extend beyond the tip leaving spaced apart opposing surfaces 76 and 78 …”; Surgical clip (10) with leg members (12) and (14), where leg member (14) includes a pair of cylindrical bosses (72 & 74) located at the distal tip on opposite sides of the leg/jaw, extending laterally/perpendicularly outward).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Jackson’s jaw structure by adding two or more perpendicularly extending cylindrical bosses/posts on one of the jaws as taught by Oh, as all the references and the claimed invention are directed to clips. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jackson’s jaw structure by adding two or more perpendicularly extending cylindrical bosses/posts on one of the jaws as taught by Oh, as such a modification would have been predictable, namely, to provide spaced-apart opposing surfaces that prevent lateral movement of the leg members relative to one another when the clip is closed, ensuring alignment and stability during latching and tissue engagement (Col. 8, line 43-46 of Oh). This modification is no more than the predictable incorporation of known lateral cylindrical boss/post features on clip jaws into a spring-biased polymeric clip (Jackson/Phillips) to improve closure alignment and prevent relative lateral shifting of the jaws during application to tissue, yielding predictable results (enhanced latching security and stability) with no unexpected technical effect.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jackson, in view of Phillips, and further in view of Pitts (US Patent No. 9347162 B1).
Regarding claim 14, Jackson teaches, the first lateral handle (first lever arm (28)) and the second lateral handle (second lever arm (30)).
Jackson fails to teach, wherein the first lateral handle and the second lateral handle include a first elongate extension post and a second elongate extension post respectively coupled thereto, wherein each of the first and second elongate extension posts extends axially and perpendicular to a longitudinal axis of the respective first lateral handle or second lateral handle, and wherein each of the first and second elongate extension posts has a first extension post end and a second extension post end.
Phillips teaches, aspects of the tissue orientation clip according to claim 1 (See above rejection of claim 1).
Pitts discloses, an alignment tool/clip/clamp. Pitts teaches, wherein the first lateral handle (Figure 3, upper plate (14); Col. 3, line 1-2) and the second lateral handle (Figure 3, lower plate (16); Col. 3, line 1-2) include a first elongate extension post and a second elongate extension post respectively coupled thereto (Figure 3, exteriorly extending enlargements (34) – one on each proximal/rearward end of upper plate (14) and lower plate (16); Col. 3, line 40-47), wherein each of the first and second elongate extension posts extends axially and perpendicular to a longitudinal axis of the respective first lateral handle or second lateral handle (Figure 3 clearly shows protruding posts/ exteriorly extending enlargements (34) perpendicular to the plates length/longitudinal axis and extending axially along the plates/handles from the proximal/rearward end), and wherein each of the first and second elongate extension posts has a first extension post end and a second extension post end (Figure 3 clearly shows the two lateral/side extremities (left and right side tips) of the exteriorly extending enlargements (34) which are considered to be the claimed extension posts ends).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Jackson’s lateral handles/lever arms by adding first and second elongate extension posts respectively coupled to the proximal/rearward ends of each handle, extending axially and perpendicular to the handle axis with defined first and second ends, as taught by Pitts, as all the references and the claimed invention are directed to clips. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jackson’s lateral handles/lever arms by adding first and second elongate extension posts respectively coupled to the proximal/rearward ends of each handle, extending axially and perpendicular to the handle axis with defined first and second ends, as taught by Pitts, as such a modification would have been predictable, namely, to provide enlarged grasping surfaces at the proximal ends for improved actuation/squeezing to open the clip jaws, enhancing ergonomic control, leverage, and ease of use during operation (Col. 3, line 26-47, “… squeezing together the rearward ends of the upper and lower plates will spread apart the forward ends… exteriorly extending enlargements… increases the distance between the between the upper and lower plates at the forward ends.”). This modification is no more than the predictable incorporation of known elongate extension posts/enlargements on proximal handle ends into a compressible pivoted clip (Jackson/Phillips) to improve actuation leverage and user grip for tissue applications, yielding predictable results (better control and opening force) with no unexpected technical effect.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jackson, in view of Phillips, and further in view of Harvey (US Patent No. 5254095 A).
Regarding claim 17, Jackson teaches, the first clip jaw (first gripping member (18)) and the second clip jaw (second gripping member (20)).
Jackson fails to teach, wherein the first clip jaw includes two teeth and the second clip jaw includes one or two teeth.
Phillips teaches, teeth on jaws according to claim 1 (See above rejection of claim 1).
Harvey discloses, a stabilizer for blood vessels. Harvey teaches, wherein the first clip jaw includes two teeth and the second clip jaw includes one or two teeth (Figures 1-5, stabilizer device with opposed panels/jaws, each terminating in forward legs (18) and rear legs (20), these legs on each panel function as two spaced-apart teeth/prongs for engaging and stabilizing tissue/vein; Col. 3, line 10-14, “…forward and rear gripping legs 18 and 20 depending therefrom. These legs 18 and 20 are relatively narrow and taper to pointed ends about the thickness of a slightly dull pencil point.”).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Jackson’s jaw configuration (as already modified by Phillips for pointed/curved teeth) by providing two teeth/prongs on one jaws and one or two on the opposing jaw, as taught by Harvey, as all the references and the claimed invention are directed to clips. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jackson’s jaw configuration (as already modified by Phillips for pointed/curved teeth) by providing two teeth/prongs on one jaws and one or two on the opposing jaw, as taught by Harvey, as such a modification would have been predictable, namely, to create a multi-point forked engagement that securely stabilizes and straightens tissue/vein without collapse or slippage, distributing pressure to minimize trauma while allowing precise access (Col. 1, line 44-49 and Col. 3, line 54-62 of Harvey).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jackson, in view of Phillips, and further in view of Bond (US Patent No. 5308358 A).
Regarding claim 18, Jackson teaches, the first lateral handle (first lever arm (28)).
Jackson fails to teach, wherein the first lateral handle is cuboid.
Phillips teaches, aspects of the tissue orientation clip according to claim 1 (See above rejection of claim 1).
Bond discloses, single-tool surgical instruments, such as scissors or forceps. Bond teaches, wherein the first lateral handle is cuboid (Figure 8 clearly shows the proximal ends of jaw components (506 & 508) that couple to lever arms (502 & 504) are cuboid, with flat sides and block-like geometry for structural coupling and grasping; Col. 8, line 61-63).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Jackson’s jaw/handle interface (as already modified by Phillips for tissue orientation) by forming the proximal portion of the first lateral handle/jaw as cuboid, as taught by Bond, as all the references and the claimed invention are directed to instrument having a pair of elongate arms pivotally coupled to one another, with a proximal handle portion and a distal working 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 Jackson’s jaw/handle interface (as already modified by Phillips for tissue orientation) by forming the proximal portion of the first lateral handle/jaw as cuboid, as taught by Bond, as such a modification would have been predictable, namely, to provide a thicker, block-shaped structure that enhances/improves ergonomic grasping near the levers. Furthermore, this modification is no more than the predictable substitution of a known cuboid/block-shaped proximal jaw/handle geometry in a pivoted instrument (Jackson/Phillips) to improve durability and handling, yielding predictable results (stronger pivot interface and better control) with no unexpected technical effect.
Claim(s) 21, 23-24, 26, 28, 31-32, 36, 41-42, 45, 47-48, 51, and 55 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jackson, in view of Phillips, and further in view of Sixto (US Patent No. 6843794 B2).
Regarding claim 21, Jackson teaches, aspects of the tissue orientation clip of claim 1 (See above rejection of claim 1).
Jackson fails to teach, a tissue orientation clip delivery system for delivering the tissue orientation clip, comprising: a delivery device comprising: an outer sheath; a plunger disposed in the outer sheath; and a clip shield coupled to a distal end of the outer sheath; and the tissue orientation clip positioned adjacent a distal end of the plunger, and coupled within the clip shield.
Phillips teaches, other aspects of the tissue orientation clip according to claim 1 (See above rejection of claim 1).
Sixto discloses, a surgical clip applier. Sixto teaches, a tissue orientation clip delivery system (Figure 1) for delivering a tissue orientation clip (Figure 2A, clip (202); Col. 9, line 66-Col. 10, line 7), comprising: a delivery device (Figure 1, flexible clip applier (10); Col. 5, line 5-7) comprising: an outer sheath (Figure 1, outer tubular coil (12); Col. 5, line 7-10); a plunger (Figure 2, clip-advancing wire (30) with pusher (34)) disposed in the outer sheath (Col. 5, line 14-16); and a clip shield (Figure 11, clip chamber (200)) coupled to a distal end of the outer sheath (Figure 11; Col. 9, line 50-60); and the tissue orientation clip (clip (202)) positioned adjacent a distal end of the plunger (Figure 2 and 11-18; Col. 9, line 55-60), and coupled within the clip shield (Figure 11; clip (202) loaded in chamber (200); Col. 9, line 50-53).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Jackson’s manual clip delivery by providing a delivery device with an outer sheath, plunger, and distal clip shield as taught by Sixto, to enable controlled, endoscopic or minimally invasive deployment of the clip, as all the references and the claimed invention are directed to clips. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jackson’s manual clip delivery by providing a delivery device with an outer sheath, plunger, and distal clip shield as taught by Sixto, to enable controlled, endoscopic or minimally invasive deployment of the clip, as such a modification would have been predictable, namely, allowing precise positioning and automatic closure on tissue without direct manual manipulation in confined surgical spaces (Col. 10-Col. 12 of Sixto). This modification is no more than the predictable substitution of a known mechanized clip delivery system (outer sheath, plunger, distal shield) for manual delivery in a spring-biased clip (Jackson) to facilitate precise, hands-free application in surgical settings, yielding predictable results (improved control and safety) with no unexpected technical effect.
Regarding claim 23, modified Jackson teaches, wherein a proximal end of the plunger includes a clip release button (Figures 6-8 of Sixto, release button (124); Col. 6, line 47-49, Col. 7, line 12-15, and Col. 11, line 55-59).
Regarding claim 24, modified Jackson teaches, further comprising a spring (Figure 7 of Sixto, torsion spring (130) around mechanism) surrounding an outer circumference of the plunger and disposed between the clip release button and the outer sheath (Col. 6, line 49-51 and Col. 7, line 12-15 of Sixto; torsion spring (130) provides return force after actuation).
Regarding claim 26, modified Jackson teaches, wherein the first and second lateral handles of the tissue orientation clip are coupled within the clip shield (Figures 2 and 11 of Sixto show the clip(s) (202) with first and second arms (204 & 206) (handles) held/engaged in/within chamber (200) (shield) with Col. 11, line 36-38 of Sixto stating, “As clip 202a is further advanced, the first and second arms 204, 206 ride in guides 170, 172, respectively, and are forced over the tissue held between the jaws 18, 20.”).
Regarding claim 28, Jackson teaches, aspects of the tissue orientation clip of claim 1 (See above rejection of claim 1).
Jackson fails to teach, a tissue orientation clip delivery system housing multiple tissue orientation clips, comprising; a delivery device comprising: a cartridge including a distal end and a proximal end, and a cartridge lumen therewithin; a plunger including a plurality of teeth; and a trigger handle including an extension arm and a catch engageable with a tooth of the plurality of teeth; and a plurality of tissue orientation clips housed within the cartridge lumen at a distal end thereof, each of the plurality of tissue orientation clips in contact with an adjacent tissue orientation clip and the most proximal of the plurality of tissue orientation clips in contact with the plunger.
Phillips teaches, other aspects of the tissue orientation clip according to claim 1 (See above rejection of claim 1).
Sixto teaches, a tissue orientation clip delivery system (Figure 1) housing multiple tissue orientation clips (Figure 2A, clips (202); Col. 9, line 50-51 and Col. 9, line 66-Col. 10, line 7), comprising; a delivery device (Figure 1, flexible clip applier (10); Col. 5, line 5-7) comprising: a cartridge (Figure 11, clip chamber (200)) including a distal end and a proximal end, and a cartridge lumen therewithin (Figure 11; Col. 9, line 50-60); a plunger including a plurality of teeth (Figure 4, clip advancing wire (30) with rack (68) as plunger with teeth; Col. 5, line 15-17 and Col. 5, line 51-56; Col. 6, line 15-17, “… the teeth of the rack (68) …”); and a trigger handle (Figure 1, handle assembly (40)) including an extension arm (Figures 1, 6, & 8, jaw closing lever (48)) and a catch (Figures 6 and 8, catch system (80)) engageable with a tooth of the plurality of teeth (Col. 5, line 26-39; Col. 6, line 26-Col. 7, line 15, catch system (80) locking tooth (90)); and a plurality of tissue orientation clips (clips (202)) housed within the cartridge lumen at a distal end thereof (Figure 11), each of the plurality of tissue orientation clips in contact with an adjacent tissue orientation clip and the most proximal of the plurality of tissue orientation clips in contact with the plunger (Col. 9, line 50-Col. 10, line 44).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Jackson’s manual clip delivery by providing a multi-clip delivery system with a cartridge lumen, plunger with teeth, trigger handle with extension arm and catch, and a plurality of clips housed in contact within the cartridge, as taught by Sixto, as all the references and the claimed invention are directed to clips. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jackson’s manual clip delivery by providing a multi-clip delivery system with a cartridge lumen, plunger with teeth, trigger handle with extension arm and catch, and a plurality of clips housed in contact within the cartridge, as taught by Sixto, as such a modification would have been predictable, namely, to enable efficient, repeated deployment of multiple clips in a single insertion without reloading, facilitating rapid markings of multiple tissue margins or specimens during surgery (Col. 9, line 50-60 and Col. 12, line 16-18 of Sixto: chamber holds linear clips with pusher advancement for sequential application). This modification is no more than the predictable substitution of a known multi-clip cartridge-based delivery system (cartridge, toothed plunger, trigger catch handle) for manual delivery in a spring-biased clip (Jackson) to allow sequential application of multiple marking clips in minimally invasive procedures, yielding predictable results (increased efficiency and reduced procedure time) with no unexpected technical effect.
Regarding claim 31, modified Jackson teaches, wherein the extension arm of the trigger handle includes a trigger handle protrusion matingly receivable by an aperture in the cartridge (In Sixto the trigger handle assembly (jaw closing lever (48) and associated handle structures) is connected to a distal extension arm in the form of tube (60), which extends from the handle housing toward the cartridge/clip chamber (given that it clamps or holds the proximal end of wire (30)). The distal end of this extension arm includes a protrusion in the form of the non-circular transition (159). The cartridge (clip chamber (200) and proximal tubular coil (12) with coil connector (152)) includes an aperture in the form of a keyhole (156) in the coil connector (152). The protrusion (transition (159)) on the extension arm of the trigger handle assembly is matingly receivable by the aperture (keyhole (156)) in the cartridge connector (coil connector (152)), thereby securing the cartridge to the handle assembly and preventing relative rotation during clip advancement and use; Col. 5, line 47-56 and Col. 8, line 40-56; Figures 2 and 4).
Regarding claim 32, modified Jackson teaches, wherein a cartridge lumen includes a track along the length of the cartridge (Figures 9-10 of Sixto, clip guides (170 & 172); Col. 9, line 35-38 and Col. 11, line 36-38 of Sixto).
Regarding claim 36, modified Jackson teaches, wherein each of the plurality of tissue orientation clips includes a post extending therefrom, wherein an end of each post is received by the track (In Sixto Figure 2A, clip arms (204 & 206) as posts; Col. 10, line 1-4; Col. 11, line 36-38, “As clip 202 a is further advanced, the first and second arms 204, 206 ride in guides 170, 172, respectively …”).
Regarding claim 41, modified Jackson teaches, wherein the trigger handle further comprises a trigger handle body having a trigger lever pivotally coupled thereto, the trigger lever biased in a non-actuated position by a compression spring housed within the trigger handle body (In Sixto, the trigger handle assembly includes a trigger handle body (housing shell portions (42 & 44)) and a trigger lever in the form of the clip-advancing lever (52), which is pivotally coupled to the jaw closing lever (48) (the main trigger lever) via pivot pin (54) (Figures 4 and 5; Col. 5, line 26-32). The trigger lever (clip-advancing lever (52)) is biased in a non-actuated position (open, away from the jaw closing lever) by a torsion spring (58) housed within the trigger handle body (Figures 4 and 7; Col. 5, line 39-42). This spring returns the clip-advancing lever to its unbiased position after actuation, readying the device for the next clip advancement).
Regarding claim 42, modified Jackson teaches, wherein the trigger handle includes a stop lever configured to engage ratcheting slots on the plunger to prevent the plunger from retracting proximally after being actuated by a trigger pull (In Sixto, the trigger handle assembly includes a stop lever in the form of the lever lock (110) (L-shaped member rotatably coupled about lever pivot (114)), which engages the locking tooth (90) on the jaw closing lever (48) (the main trigger lever) to lock the lever in position after actuation (Figures 6-8; Col. 6, line 42-51 and Col. 7, line 8-10). The plunger (clip-advancing wire (30) with rack (68)) has ratcheting structure in the form of the rack teeth (68), which interact with the pinion (70) on the clip-advancing lever (Figure 4; Col. 6, line 15-17). The stop lever (lever lock (110)) prevents proximal retraction of the plunger by locking the overall trigger/actuation system after firing (Col. 6, line 49-55; torsion spring (130) biases the lock into engagement)).
Regarding claim 45, modified Jackson teaches, wherein a proximal end of the plunger extends past the proximal end of the cartridge and is received within an upper channel of the trigger handle (Figure 4 of Sixto; Col. 5, line 48-51 of Sixto, wire (30) extends to handle, “… proximal end of the clip-advancing wire 30 is clamped, or otherwise held, within the tube 60 …”).
Regarding claim 47, Jackson teaches, aspects of the tissue orientation clip of claim 1 (See above rejection of claim 1.
Jackson fails to teach, a method of delivering one or more tissue orientation clips of claim 1 to a tissue specimen in a patient, the method comprising: providing a delivery system that delivers the one or more tissue orientation clips, the system comprising: a delivery device, comprising: a cartridge including a distal end and a proximal end, and a cartridge lumen therewithin; a plunger including a plurality of teeth; a trigger handle including an extension arm and a catch engageable with a tooth of the plurality of teeth; and a plurality of the tissue orientation clips housed within the cartridge lumen at a distal end thereof, each of the plurality of tissue orientation clips in contact with an adjacent tissue orientation clip and the most proximal of the plurality of tissue orientation clips in contact with the plunger; inserting the delivery system into the patient proximate the tissue specimen; and expelling a first tissue orientation clip of the plurality of tissue orientation clips from the distal end of the cartridge by actuating the trigger handle to move the catch and advance the plunger.
Phillips teaches, other aspects of the tissue orientation clip according to claim 1 (See above rejection of claim 1).
Sixto teaches, a method of delivering one or more tissue orientation clips to a tissue specimen in a patient (Col. 1, line 10-14 and Col. 2, line 27-29), the method comprising:
providing a delivery system (Figure 1) that delivers the one or more tissue orientation clips (Figure 2A, clips (202); Col. 9, line 50-51 and Col. 9, line 66-Col. 10, line 7), the system comprising:
a delivery device (Figure 1, flexible clip applier (10); Col. 5, line 5-7), comprising:
a cartridge (Figure 11, clip chamber (200)) including a distal end and a proximal end, and a cartridge lumen therewithin (Figure 11; Col. 9, line 50-60);
a plunger including a plurality of teeth (Figure 4, clip advancing wire (30) with rack (68) as plunger with teeth; Col. 5, line 15-17 and Col. 5, line 51-56; Col. 6, line 15-17, “… the teeth of the rack (68) …”);
a trigger handle (Figure 1, handle assembly (40)) including an extension arm (Figures 1, 6, & 8, jaw closing lever (48)) and a catch (Figures 6 and 8, catch system (80)) engageable with a tooth of the plurality of teeth (Col. 5, line 26-39; Col. 6, line 26-Col. 7, line 15, catch system (80) locking tooth (90)); and
a plurality of tissue orientation clips (clips (202)) housed within the cartridge lumen at a distal end thereof (Figure 11), each of the plurality of tissue orientation clips in contact with an adjacent tissue orientation clip and the most proximal of the plurality of tissue orientation clips in contact with the plunger (Col. 9, line 50-Col. 10, line 44);
inserting the delivery system into the patient proximate the tissue specimen (clip applier (10) is inserted through endoscope working channel to tissue site; Col. 5, line 5-7 and Col. 10, line 62-67); and
expelling a first tissue orientation clip of the plurality of tissue orientation clips from the distal end of the cartridge by actuating the trigger handle to move the catch and advance the plunger (actuating clip-advancing lever (52) rotates pinion (70) to advance rack (68) and clip-advancing wire (30)/plunger, moving catch system (80) to release/advance (Col. 6, line 26-55, Col. 9, line 50-60, and Col. 11, line 22-53); Col. 6, line 26-Col. 7, line 15, catch system (80)/locking tooth (90) moves to allow advancement; pusher (34) expels distalmost clip (202a) over tissue; Figures 11, 17-18, and 19-21 show sequence, actuation advances plunger, clip is expelled and formed on tissue).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Jackson’s manual clip application by using a multi-clip delivery method with insertion, trigger actuation to move catch and advance plunger for clip expulsion, as taught by Sixto), as all the references and the claimed invention are directed to clips. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jackson’s manual clip application by using a multi-clip delivery method with insertion, trigger actuation to move catch and advance plunger for clip expulsion, as taught by Sixto), as such a modification would have been predictable, namely, to enable precise, repeated, minimally invasive deployment of multiple clips onto tissue sites without reloading, facilitating efficient marking of multiple margins or specimens during endoscopic or laparoscopic procedures (Col. 5, line 26-45 of Sixto, controlled advancement via trigger/lever for clip application; Col. 9, line 50-60 and Col. 12, line 16-18 of Sixto, sequential expulsion of chained clips). This modification is no more than the predictable use of a known multi-clip endoscopic delivery method (providing system, inserting, actuating trigger to advance plunger and expel clip) in place of manual application for a spring-biased marking clip (Jackson/Phillips), yielding predictable results (improved precision, speed, and minimally invasive capability) with no unexpected technical effect.
Regarding claim 48, modified Jackson teaches, wherein expelling the first tissue orientation clip of the plurality of tissue orientation clips includes squeezing a trigger lever on the trigger handle (In Sixto, the trigger handle assembly includes a trigger handle body (housing shell portions (42 & 44)) and a trigger lever in the form of the clip-advancing lever (52), which is pivotally coupled to the jaw closing lever (48) (the main trigger lever) via pivot pin (54) (Figures 4 and 5; Col. 5, line 26-32); the trigger lever is squeezed/rotated to advance plunger and expel clip).
Regarding claim 51, modified Jackson teaches, wherein expelling the first tissue orientation clip of the plurality of tissue orientation clips includes transitioning the first tissue orientation clip of the plurality of tissue orientation clips from an open position to a closed position on the tissue site (In Sixto, Figures 17-19 show clip advancing open then closing/forming on tissue; Col. 11, line 38-40, clip (202a) advanced through jaws (18, 20), forced against anvil (184), retainer (214) of clip (202) bent to close/latch over tissue).
Regarding claim 55, modified Jackson teaches, wherein when the first tissue orientation clip of the plurality of tissue orientation clips is expelled, a second tissue orientation clip of the plurality of tissue orientation clips advances to the distal end of the cartridge (In Sixto, Figures 19-21, next retainer (214b) protrudes after expulsion; Col. 11, line 31-35, Col. 12, line 1-4, and Col. 12, line 16-18; After clip (202a) expulsion, torsion spring (58) retracts clip-advancing wire (30)/pusher (34), allowing next clip (202b) to advance distally via chain effect).
Response to Arguments
Applicant’s arguments, filed 11/10/2025, with respect to claim(s) 1-2, 4, 6, 11-12, 14, 17-19, 21, 23-24, 26, 28, 31-32, 36, 41-42, 45, 47-48, 51 and 55 under 35 U.S.C. 102(a)(2) and 103 have been considered but they are moot in view of the new ground(s) of rejection.
The new ground(s) of rejection rely on Jackson (US Patent No. 5381989 A) in view of Phillips (US Patent No. 8594768 B2) and further in view of Oh (US Patent No. 4834096 A), Pitts (US Patent No. 9347162 B1), Harvey (US Patent No. 5254095 A), Bond (US Patent No. 5308358 A), or Sixto (US Patent No. 6843794 B2), which are different from the references applied in the prior rejection of record (Bagley (US 2022/0000485 A1), Phillips (US 2007/0270681 A1), Roundy (US 2018/0116669 A1), and Malkowski (US 2015/0351771 A1)). The arguments specifically challenged teachings in the prior art of record regarding “a spring including a first spring arm received in the first spring arm receiving slot and a second spring arm received within the second spring arm receiving slot” as recited in independent claim 1. However, the new ground(s) of rejection do not rely on Bagley, Phillips, Roundy, or Malkowski for any teachings or matter or matter challenged in the arguments, including the spring and receiving slot limitations. Therefore, the arguments are moot and do not apply to the new ground(s) of rejection. See MPEP 1207.02(A)(2) (Arguments not commensurate with the rejection will not be considered persuasive).
See updated rejections above.
Conclusion
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/O.N./Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771