DETAILED ACTION
Claims 1, 6, 32, and 51 are amended. Claims 2 and 17 are canceled. Claim 56 is a newly added claim. A complete action on the merits of pending claims 1, 4, 6, 11-12, 14, 18-19, 21, 23-24, 26, 28, 31-32, 36, 41-42, 45, 47-48, 51, and 55-56 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 05/22/2026 which are entered. With regards to the claim objection documented in the Non-Final Office Action sent on 02/23/2026, it is overcome through Applicant’s amendment to claim 32 and is withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 56 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 56 recites, “the first spring arm receiving slot and the second spring arm receiving slot have a width of less than twice a diameter of the first spring arm and the second spring arm.” Applicant's reply (Page 1 of the “Remarks” filed on 05/22/2026) points solely to the figures (e.g., Figures 6-7, 9, and 12) for support of this dimensional limitation. However, drawings alone do not provide a sufficient written description of a specific mathematical ratio or relative dimensional boundary unless the specification or the drawings themselves present a clear, verifiable representation or measurement protocol that conveys to one of skill in the art that the inventor possessed this exact quantitative limitation at the time of filing. The referenced figures lack explicit dimensions, scale, or descriptive text establishing that the slot width is restricted to less than twice the arm diameter rather than varying outside that ratio. The specification also did not provide any support for the dimensional limitation claimed explicitly or inherently.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
Claim(s) 1, 4, 11, and 56 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jackson (US Patent No. 5381989 A), in view of Harvey (US Patent No. 5254095 A).
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)) positioned 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), the second clip jaw coupled to and rotatable in relation to the first clip jaw about an axis extending substantially in the first direction (Col. 2, line 52-54, discloses, “The conventional clamp 12 includes first and second gripping members 18 and 20 pivotally coupled to a pivot pin 22.” Where as seen in the Figures, the pivot pin (22) is extending in a perpendicular/lateral direction (first direction) relative to the longitudinal axis of the clamp (10)) so that the tissue orientation clip is movable between a gripping position at which the first and second clip jaws are relatively positioned so as to grip a tissue specimen (Col. 2, line 45-48, discloses, “The adjustable spring clamp 10 includes a conventional clamp 12 having a coil spring 14 for biasing the clamp 12 toward a gripping position shown in the drawings…” In the gripping position, first and second gripping members (18 & 20) are indeed capable of gripping a tissue specimen), and a releasing position at which the first and second clip jaws are relatively positioned so as to release the tissue specimen (Col. 1, line 38-41, discloses, “…an adjustable clamp comprises first and second gripping members coupled together for pivotal movement about a pivot pin between a gripping position and a releasing position…,” Where the releasing position allows the first and second gripping members (18 & 20) to be indeed capable of release of the tissue specimen); and
a spring (Figure 1, helically coiled spring (14)) including a first and a second spring arm (Figure 1, first end extension (40) & second end extension (42)), the first and the second spring arms (first end extension (40) & second end extension (42)) being received in the respective first and second spring arm receiving slots so that the spring exerts a biasing force that urges the first and second arms toward the gripping position (Figures 1-3; Col. 2, line 45-48 and Col. 2, line 62-Col. 3, line 6),
wherein the spring (spring (14)) is calibrated so that the first and second clip jaws (first and second gripping members (18 & 20)), when in the gripping position, exert a gripping force on the tissue specimen, the gripping force being large enough to securely attach the tissue orientation clip to the tissue specimen and low enough to minimize damage to the tissue specimen (Col. 2, line 49-51, discloses, “…an adjustment mechanism 16 for changing the tension of the spring 14 to adjust the bias of the spring 14, and therefore, the gripping strength of the clamp 12.” The adjustment in gripping strength allows for the gripping force on the tissue specimen to be large enough to securely attach the clamp (10) to the tissue specimen and low enough to minimize damage to the tissue specimen).
Jackson does not explicitly teach teeth on jaws, specifically, the first clip jaw including at least two teeth positioned at a distal end of the first clip jaw and spaced apart in a first direction; the second clip jaw including at least one tooth positioned at a distal end of the second clip jaw; and wherein the gripping/gripping force and releasing of the first and second clip jaws of the tissue specimen occurs at/through the teeth of the first and second clip jaws.
Harvey discloses, a stabilizer for blood vessels. Harvey teaches, the first clip jaw includes at least two teeth positioned at a distal end of the first clip jaw and spaced apart in a first direction (perpendicular/lateral direction relative to longitudinal direction) and the second clip jaw includes at least one tooth positioned at a distal end of the second clip jaw; wherein the gripping/gripping force and releasing of the first and second clip jaws of the tissue specimen occurs at/through the teeth of the first and second clip jaws (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 by providing at least two teeth/prongs positioned at a distal end of the first clip jaw and spaced apart in a first direction and at least one tooth positioned at a distal end of the second clip jaw, as taught by Harvey, such that the gripping/gripping force and releasing of the first and second clip jaws of the tissue specimen occurs at/through the teeth of the first and second clip jaws, 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 make this modification, 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).
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 11, Jackson in view of Harvey 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). Harvey further provides motivation to optimize the clip size downward for small tissue specimens (Col. 3, line 40-45). 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 during application/deployment. 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 56, Jackson in view of Harvey teach the claimed invention except for, “the first spring arm receiving slot and the second spring arm receiving slot have a width of less than twice a diameter of the first spring arm and the second spring arm.” 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 width of arms (28 & 30) to be less than twice a diameter of the of extensions (40 & 42), 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 teaches the structural arrangement of spring arms seated in housing slots and a person of ordinary skill in the art at the time of the invention would have found it obvious to size the width of the receiving slots relative to the arm diameter through routine optimization to ensure a proper fit or clearance. In re Aller.
Claim(s) 6 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jackson, in view of Harvey, and further in view of Phillips (US Patent No. 8594768 B2).
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 an indicum indicating an orientation of a tissue specimen.
Harvey teaches, aspects of the tissue orientation clip according to claim 1 (See above rejection of claim 1).
Phillips discloses, a tissue marking clip. Phillips teaches, a tissue orientation clip (Figure 12, clip (230); Col. 8, line 22-24) further comprising an indicum (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 indicum (e.g., numbered/opaque balls or markers on a tail/extension portion) as taught by Phillips, 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 make this modification, 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 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.
Harvey teaches, aspects of the tissue orientation clip according to claim 1 (See above rejection of claim 1).
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 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 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) 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 Harvey, and further in view of Oh (US Patent No. 4834096 A).
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.
Harvey 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 make this modification, 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 clip (Jackson) 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 Harvey, and further in view 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.
Harvey 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 make this modification, 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 of Pitts, “… 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) 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) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jackson, in view of Harvey, and further in view 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.
Harvey 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 Harvey 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 make this modification, 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) 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 Harvey, and further in view 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.
Harvey 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 make this modification, 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 of Sixto).
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.
Harvey 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 make this modification, 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 of Sixto; Figures 2 and 4 of Sixto).
Regarding claim 32, modified Jackson teaches, wherein the cartridge lumen includes a track along a 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 of Sixto; Col. 11, line 36-38 of Sixto also, “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 of Sixto; Col. 5, line 26-32 of Sixto). 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 of Sixto; Col. 5, line 39-42 of Sixto). 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 of Sixto; Col. 6, line 42-51 and Col. 7, line 8-10 of Sixto). 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 of Sixto; Col. 6, line 15-17 of Sixto). 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 of Sixto; 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.
Harvey 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 make this modification, 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 clip (Jackson), 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 of Sixto; Col. 5, line 26-32 of Sixto); 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 a tissue site (In Sixto, Figures 17-19 show clip advancing open then closing/forming on tissue; Col. 11, line 38-40 of Sixto, 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 of Sixto; 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 on 05/22/2026 with respect to the rejections of claims 1, 4, 6, 11-12, 14, 18-19, 21, 23-24, 26, 28, 31-32, 36, 41-42, 45, 47-48, 51, and 55 have been fully considered but they are not persuasive.
With regards to the “Analogous Art” argument: Jackson is analogous art. A reference is analogous if it is from the same field of endeavor or is reasonably pertinent to the particular problem with which the inventor is involved. Jackson discloses a spring-biased clamp having first and second gripping members (jaws) pivotally coupled about a pivot pin, lateral lever arms, and a helically coiled spring whose end extensions engage the lever arms to bias the jaws toward a gripping position, with an adjustment mechanism for varying spring tension/gripping force (as outlined in the mapping of the claims limitations above). The claimed invention is a spring-biased tissue orientation clip having first and second clip jaws with lateral handles, spring arms received in slots defined by the handles, and a spring calibrated to provide a gripping force large enough to securely attach the clip yet low enough to minimize tissue damage. Both devices solve the problem of providing a compact, spring-biased clamping structure whose gripping force can be controlled. A person of ordinary skill in the art seeking a spring-biased clip for secure yet atraumatic attachment of a marker to tissue would reasonably look to known adjustable spring clamps. The surgical end-use of the claimed device does not render Jackson non-analogous; the structural and functional similarities are sufficient under MPEP 2141.01(a).
With regards to the “Spring Arm Receiving Slots”: Applicant contends that Jackson’s end extensions (40, 42) merely “press against” the lever arms and that the adjustment mechanism requires free movement inconsistent with a slot. The Examiner respectfully disagrees. Jackson expressly states that the spring “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” (Col. 2, line 63-Col. 3, line 6). Figures 1-3 show the extensions seated within the lever arms in a manner that constrains their position sufficiently to transmit the biasing force while still permitting the disclosed adjustment (bar (52) repositioning extension (40)). The claim language requires only that each lateral handle “defin[e] a … spring arm receiving slot therein” and that the spring arms be “received in” those slots. Jackson’s arrangement satisfies this language under the broadest reasonable interpretation (MPEP 2111). Even if the precise geometry of Jackson’s engagement differs slightly from the preferred embodiment shown in Applicant’s figures, the structural and functional correspondence is sufficient to render the feature obvious when combined with the secondary references teaching the remaining claim elements.
With regards to “Calibrated Spring/Gripping Force”: Amended claim 1 requires that “the spring is calibrated so that the teeth … exert a gripping force … large enough to securely attach the tissue orientation clip to the tissue specimen and low enough to minimize damage.” Jackson teaches precisely such calibration: an adjustment mechanism “for changing the tension of the spring 14 to adjust the bias of the spring 14, and therefore, the gripping strength of the clamp 12” (Col. 2, line 49-51). Selecting a particular tension that is high enough for secure attachment yet low enough to avoid damage is nothing more than the routine exercise of the very adjustment capability Jackson provides. No unexpected result is shown; the claimed calibration is the predictable result of using Jackson’s adjustable spring in a tissue-gripping context (MPEP 2144.05).
With regards to “Teeth and Teaching Away”: Jackson does not teach away from the addition of teeth. Teaching away requires that the reference criticize, discredit, or otherwise discourage the claimed solution (MPEP 2143.01(V); In re Fulton, 391 F.3d 1195 (Fed. Cir. 2004)). Jackson’s elastomeric covers (74 & 76) are disclosed merely as an optional feature “to prevent the jaws 24 and 26 from marring any article held therein” (Col. 4, line 18–23). The presence of an optional protective covering does not criticize or discourage the use of teeth; it simply addresses a different design consideration. Harvey expressly teaches the claimed tooth arrangement (at least two spaced-apart teeth on one jaw and at least one tooth on the opposing jaw) for engaging tissue with minimal trauma (Figures 1-5; Col. 3, line 10-14). Combining Jackson’s adjustable spring-biased clamp with Harvey’s multi-point forked teeth yields the predictable result of a clip that grips securely at discrete points while distributing force to minimize damage-exactly the result recited in claim 1. Phillips is now relied upon only for the indicium limitation of claim 6 and the material limitation of claim 19; it is not necessary to supply the teeth or the calibrated spring.
Dependent Claims and Secondary References:
Because independent claim 1 remains obvious over Jackson in view of Harvey (and further in view of the additional references as set forth in the rejections), the dependent claims that rely solely on the alleged deficiencies of claim 1 are likewise unpatentable.
Claim 12: Oh supplies the perpendicular posts/bosses on a clip jaw (Figure 1; Col. 5, line 40-49). The combination remains obvious for the reasons previously stated.
Claim 14: Pitts supplies elongate extension posts/enlargements on the proximal ends of the handles that improve grasping and leverage (Figure 3; Col. 3, line 1-47). Even if Pitts is drawn from the sewing arts, it is reasonably pertinent to the problem of providing improved proximal actuation surfaces on a pivoted clamp; the modification is therefore proper (MPEP 2141.01(a)). The argument that the enlargements are not “coupled to” discrete posts is unpersuasive under the broadest reasonable interpretation.
Claim 18: Bond supplies a cuboid proximal handle geometry (Figure 8). The modification is a simple design choice that improves ergonomics and structural strength.
Claims 21, 23-24, 26, 28, 31-32, 36, 41-42, 45, 47-48, 51, and 55 (delivery systems and methods): Sixto supplies the claimed outer sheath/plunger/clip-shield single-clip delivery device and the cartridge/plunger-with-teeth/trigger-handle multi-clip delivery device and corresponding methods of use (Figures 1-2, 4, 6-8, 11, 17-21; Col.’s 5-12). Once the clip of claim 1 is rendered obvious, substituting the known delivery systems of Sixto for manual application is the predictable use of a known technique to improve a similar device (MPEP 2143).
See updated rejections above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/O.N./Examiner, Art Unit 3771
/TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771
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