DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant' s arguments, filed 12/22/2025, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 12/22/2025, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1, 3-12, 14, and 16-19 are the currently pending claims. Claims 2, 13, and 15 have been canceled; Claims 3-4, 7-12, 16-17, and 20 have been withdrawn; and claims 1, 5-6, 14, and 18-19 are hereby under examination.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1 and 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Jensen et al. (US-20160095646-A1), hereto referred as Jensen, and further in view of Shadduck et al. (US-20130090642-A1), hereto referred as Shadduck, and further in view of Kuo et al. (Kuo, Ramsay L et al. “Holmium Laser Enucleation of the Prostate (HoLEP): A Technical Update.” World journal of surgical oncology 1.1 (2003): n. pag. Web.), hereto referred as Kuo, and further in view of Kortenbach et al. (US-5707392-A), hereto referred as Kortenbach.
Regarding claim 1, Jensen teaches a device for at least partial insertion into a patient (Jensen, [0064]: "The above-described bipolar forceps embodiments may be suitable for utilization with endoscopic Surgical procedures and/or hand-assisted, endoscopic and laparoscopic surgical procedures", this teaches use in endoscopic procedures connoting at least partial insertion into a patient).
Also regarding claim 1, Jensen does not fully teach that the device comprises: an elongated sheath having a proximal portion, a distal portion and a lumen, the elongated sheath being partially insertable into a patient. Rather, Jensen teaches an endoscopic bipolar forceps intended for minimally invasive and endoscopic surgical procedures, which establishes use in an endoscopic access setting, but Jensen does not disclose that the claimed device itself includes an elongated sheath having a lumen (Jensen, FIG. 1; [0015], [0064]).
Shadduck, similarly to Jenson, teaches that the "invention relates to systems and methods for cutting and extracting tissue in endoscopic surgeries" (Shadduck, [0003]). It goes on to demonstrate a sleeve with a lumen: "A surgical tissue cutting and extraction device includes a sleeve having a tissue extraction lumen. One or more jaw members are coupled to the sleeve and configured to pivot or flex relative to the sleeve to capture tissue" (Shadduck, Abstract).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Jensen in view of Shadduck to provide an elongated sheath with a lumen for partial insertion into the patient. The combination would have been feasible because Jensen expressly contemplates use in endoscopic surgical procedures and teaches that its end-effector configurations may be fabricated and assembled depending upon a particular purpose, which supports adapting the Jensen forceps geometry for use within a sleeve/lumen architecture as taught by Shadduck (Jensen, [0064]; [0063]). Further, routing and protecting instrument components through a sleeve or working channel is a routine packaging choice in endoscopic systems. The benefit would be a protected working channel for access, visualization, irrigation/suction and tissue extraction, improving procedural efficiency and reducing instrument exchanges.
Also regarding claim 1, the modified Jensen does not fully teach that an elongated member extends longitudinally within the lumen of the elongated sheath; and a tissue engagement tool located at a distal portion of the elongated member. Rather, the modified Jensen teaches a shaft and distal jaws, stating "a shaft including a distal end and a proximal end... and an end-effector assembly coupled to the distal end of the shaft and including first and second jaw members" (Jensen, [0012]) and "Forceps 10 includes an elongated shaft 50... Shaft 50 extends from the housing 20 and supports movement of other components therethrough" (Jensen, [0031]). However, it does not disclose that the elongated member extends within the lumen of an elongated sheath that is part of the device, although it is designed for use in endoscopic surgeries (Jensen, [0064]).
Similarly, Shadduck teaches "an electrosurgical tissue resection device comprises a shaft extending to a working end comprising first and second clamp elements... for capturing a tissue mass, and an RF electrode carried by the working end for resecting tissue" (Shadduck. [0013]), but also describes "an axially-extending sleeve having a tissue extraction lumen wherein a distal end portion of the sleeve comprises... one or more jaw members coupled to the sleeve wherein the... jaw and sleeve are axially moveable relative to one another" (Shadduck. [0007]). These disclosures illustrate a lumen-based sleeve architecture guiding axially movable working-end components relative to the sleeve and cooperating with a distal tissue-engaging structure, without requiring that the sleeve itself be the elongated member.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Jensen in view of Shadduck to position the elongated member (e.g., a shaft or inner component) within the lumen of an elongated sheath and to carry a distal tissue engagement tool. The combination would have been feasible because Jensen already provides the distal jaws and actuated shaft designed for endoscopic procedures, and Shadduck provides a directly compatible lumen-based sleeve architecture for housing and guiding inner components. The benefit would be improved access control and integrated extraction/working-channel management while preserving precise actuation of the distal tissue-engaging tool.
Also regarding claim 1, the modified Jensen does not fully teach that a laser fiber extends longitudinally with the elongated sheath the laser fiber located at the distal portion of the elongated sheath. Rather, the modified Jensen teaches the laser/optical fiber orientation and distal placement, stating "The terms "end-firing" and "longitudinal-firing" as used herein denote a laser fiber that has the capability to emit light along a longitudinal axis of the fiber. For the purposes of this description, the terms "laser fiber" and "optical fiber" are used interchangeably" (Jensen, [0024]) and "end-effector assembly 100 may include a laser emitter ... coupled to the distal end of the longitudinal-firing optical fiber 61" (Jensen, [0048]). It goes on to show the laser coupled with the jaws of the device (Jensen, FIG. 3-6). However, it does not disclose that these fibers extend longitudinally with an elongated sheath having a lumen as part of the device.
As already discussed above, Shadduck teaches the elongated sheath that Jensen's device would traverse in practice. As the modified Jensen's laser fiber is depicted traversing the length of the devices shaft, as the device is inserted into the sheath it would necessarily extend longitudinally with the elongated sheath.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Jensen in view of Shadduck to route the longitudinal laser fiber extend with the elongated sheath to the distal portion of the instrument. The combination would have been feasible because Jensen's fiber already extends longitudinally to the distal end-effector, and Shadduck's sleeve-with-lumen architecture provides a straightforward physical channel to co-locate and protect elongated elements. The benefit would be reliable fiber guidance and protection during insertion and manipulation, maintaining alignment and reducing the risk of fiber damage while preserving a clear working corridor for the distal surgical action.
Also regarding claim 1, the modified Jensen does not fully teach that the laser fiber being configured to laser enucleate tissue. Rather, the modified Jensen teaches an endoscopic bipolar forceps that integrates longitudinal-firing optical fibers at the distal end for treating tissue, including discussion of Ho:YAG lasers and minimally invasive use (Jensen, [0062]; [0024]; [0048]). Jensen also details these types of lasers as being appropriate for enucleation (Jensen, [0007]: "A common laser-based surgical procedure is holmium laser enucleation of the prostate (HoLEP). In this procedure, a holmium: yttrium aluminium garnet (Ho:YAG) laser is used to remove obstructive prostate tissue"). However, it does not expressly teach performing laser "enucleation" with the disclosed forceps.
Kuo teaches that "...the holmium: YAG laser... has found widespread urologic applications, especially in the treatment of urolithiasis[3] Because the laser's wavelength is highly absorbed by water[4], it is also an effective tool for the ablation and cutting of soft tissue. These characteristics naturally extend into applications for BPH... the spectrum of treatment has progressed from simple vaporization of tissue to the complete removal, or enucleation, of intact lobes of prostatic adenoma... holmium laser enucleation of the prostate (HoLEP) combined with mechanical morcellation represents the latest refinement of the resection technique" (Kuo, p. 2, Introduction).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Jensen in view of Kuo to perform laser enucleation with the distal laser fiber. The combination would have been feasible because Jensen expressly uses laser/optical fibers at the distal end of an endoscopic forceps and Kuo provides operative parameters and procedural context for HoLEP using holmium laser fibers in an endoscopic setting. The benefit would be to leverage the known enucleation capabilities of holmium lasers within an integrated end-effector platform to enable efficient tissue removal consistent with clinical HoLEP practice.
Also regarding claim 1, the modified Jensen does not fully teach that the tissue engagement tool being configured to morcellate tissue. Rather, the modified Jensen teaches distal jaw members on endoscopic forceps that grasp tissue and are actuated via a handle (Jensen, [0012]; [0042]). Additionally, it teaches that the jaws "may be configured to provide monopolar electrosurgical energy and/or bipolar electrosurgical energy, which may be suitable for sealing, cauterizing, coagulating, desiccating, and/or cutting tissue" (Jensen, [0027]). However, it does not expressly say that these actions are used for morcellation of tissue.
Shadduck teaches a jaw-equipped endoscopic/laparoscopic device “adapted for laparoscopic tissue morcellation,” including working-end embodiments in which the jaw/clamp members themselves carry the morcellation structures (Shadduck, FIG. 5-6; ¶[0050]–¶[0052]). In particular, Shadduck teaches a working end with “opposing jaw or clamp member[s]” and discloses that a jaw/clamp member is “configured with the RF cutting sleeve and tissue extraction channel” (Shadduck, ¶[0051]). Shadduck further teaches an embodiment in which “both clamp members … are configured with RF cutting sleeves and tissue extraction channels,” and that “tissue extraction channels can merge into a single channel in shaft 645” (Shadduck, ¶[0052]). Thus, in the combined device, the claimed tissue engagement tool corresponds to Shadduck’s jaw/clamp members that (i) grasp tissue and (ii) include RF cutting sleeve(s) for morcellation and (iii) include tissue extraction channel(s) for removal through the instrument (Shadduck, ¶[0051]–¶[0052]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Jensen in view of Shadduck to provide a tissue engagement tool that is actuatable for morcellation of tissue. The combination would have been feasible because Jensen already discloses endoscopic jaws and actuation mechanisms at the distal end of a shaft for cutting tissue with RF energy, and Shadduck demonstrates that RF jaws are actuatable for morcellation. The benefit would be to enable integrated tissue removal following tissue treatment, reducing instrument exchanges and improving procedural efficiency in endoscopic surgery.
Also regarding claim 1, the modified Jensen does not fully teach that the tissue engagement tool is configured to retract the tissue proximally through the elongated sheath, the laser fiber and the tissue engagement tool being configured to substantially move together relative to the elongated sheath while the tissue engagement tool retracts the tissue proximally through the elongated sheath.
Rather, the modified Jensen teaches an endoscopic forceps with jaw members configured to grasp tissue, stating "jaw members 110 and 120 cooperate to grasp tissue there between" (Jensen, [0041]), and further teaches a longitudinal-firing optical fiber disposed at the distal jaw member such that the fiber is carried with the distal end-effector (Jensen, [0039]-[0041]). Jensen also teaches suitability for endoscopic surgical procedures and that jaw member configurations may be fabricated and assembled into various end-effector configurations depending upon a particular purpose (Jensen, [0064]; [0063]). However, the modified Jensen does not expressly teach using the tissue engagement tool to retract captured tissue proximally through an elongated sheath lumen while the laser fiber and tissue engagement tool move together relative to the elongated sheath during such retraction.
Kortenbach teaches performing an endoscopic procedure using an endoscope having a lumen, advancing jawed forceps through the lumen to capture tissue, and then withdrawing the instrument through the endoscope while maintaining the jaws closed such that the captured tissue is retracted proximally through the lumen: "The endoscope typically includes a long narrow flexible tube with an optical lens and a narrow lumen for receiving a biopsy forceps" and the practitioner "inserts the biopsy forceps through the lumen of the endoscope" and, "After a sample has been obtained, the practitioner and/or an assistant carefully withdraws the instrument from the endoscope while holding the actuating handle to maintain the jaws in a closed position" (Kortenbach, col. 2, ll. 9-24). In the combined device of the modified Jensen as further modified in view of Shadduck, the claimed elongated sheath lumen corresponds to Shadduck's sleeve/tissue extraction lumen, and Kortenbach is relied upon for the well-known endoscopic technique of withdrawing a jawed instrument through a lumen while maintaining jaw closure to retain tissue, which would have been applied to retract tissue proximally through Shadduck's sleeve lumen.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Jensen in view of Kortenbach to use the distal jawed tissue engagement tool to retract captured tissue proximally through the elongated sheath lumen while the distal jawed tissue engagement tool and the laser fiber move together relative to the elongated sheath during withdrawal. The combination would have been feasible because both Jensen and Kortenbach concern endoscopic jawed instruments advanced through a lumen/sheath, and Kortenbach is relied upon only for the well-known technique of withdrawing a jawed instrument through the lumen/sheath while maintaining jaw closure to retain tissue. Additionally, the combination would have been feasible because Jensen already provides jaw members that grasp tissue and a longitudinal-firing optical fiber carried with the distal end-effector, and Jensen expressly contemplates use in endoscopic surgical procedures and configuring end-effector geometries for a particular purpose (Jensen, [0041]; [0039]-[0041]; [0064]; [0063]). Kortenbach teaches withdrawing a jawed instrument through an endoscope lumen while maintaining the jaws closed to retain tissue, which corresponds to retracting tissue proximally through the sleeve/sheath lumen during proximal movement (Kortenbach, col. 2, ll. 9-24). The benefit would be enabling reliable proximal removal of captured tissue through a protected lumen while maintaining the laser fiber and tissue engagement tool in a coordinated endoscopic configuration, thereby reducing instrument exchanges and improving procedural efficiency in lumen-based surgery.
Regarding claim 5, as shown in claim 1 above, the modified Jensen teaches that the tissue engagement tool is a morcellator (The combined device (modified Jensen) includes the Shadduck jaw-fed RF cutting sleeve and tissue-extraction channel, i.e., a morcellator, so the additional limitation of claim 5 is satisfied by the same combined device without further modification; Shadduck, ¶[0050]; ¶[0052]).
Regarding claim 6, as shown in claim 1 above, the modified Jensen partially teaches that the morcellator comprises a bipolar morcellator comprising jaws actuatable for grasping tissue and at least two electrodes actuatable for providing radio frequency energy to the tissue. The combined device, as shown in claim 1 above, already provides an endoscopic instrument having a morcellator working end, integrated with Jensen’s jawed bipolar forceps, with tissue grasping action (as per Kortenbach), platform and Kuo’s laser-enucleation procedural context (Shadduck, ¶[0050]; ¶[0052]). However, it does not expressly say that the morcellator is bipolar with two electrodes.
Shadduck explicitly states that there are at least two RF electrodes on the jaws (Shadduck, claim 59: "both the first and second jaw members carry RF electrodes", see also FIG. 4-8 and ¶[0050]-[0054]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Jensen in view of Shadduck’s RF electrode teachings with Jensen’s bipolar configuration to provide a bipolar morcellator having jaws actuatable for grasping tissue and at least two electrodes actuatable for providing radio-frequency energy to the tissue. The combination would have been feasible because Jensen’s jawed forceps architecture already implements bipolar delivery with conductive elements on each jaw, and Shadduck’s morcellation working ends are designed to place RF structures/electrodes on both jaws while feeding tissue into an RF cutting sleeve; integrating the bipolar jaw electrode arrangement with the morcellator end is a straightforward alignment of known jaw-electrode placements and the morcellation mechanism. The benefit would be reliable bipolar energy delivery across grasped tissue during morcellation, improving cutting efficiency and hemostasis while maintaining the integrated capture-and-extraction pathway of the morcellator.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Jensen et al. (US-20160095646-A1), hereto referred as Jensen, and further in view of Shadduck et al. (US-20130090642-A1), hereto referred as Shadduck, and further in view of Kuo et al. (Kuo, Ramsay L et al. “Holmium Laser Enucleation of the Prostate (HoLEP): A Technical Update.” World journal of surgical oncology 1.1 (2003): n. pag. Web.), hereto referred as Kuo, and further in view of Kortenbach et al. (US-5707392-A), hereto referred as Kortenbach, and further in view of Lonky et al. (US-20190224463-A1), hereto referred as Lonky.
The modified Jensen teaches claim 1 as described above.
Regarding claim 14, the modified Jensen does not teach that device further comprises a delivery tube configured to delivery of a medicated gel, the delivery tube situated within the lumen of the elongated sheath. Rather, the modified Jensen establishes an endoscopic device with an elongated sheath having a lumen for housing and guiding instrument components, but it does not disclose a delivery tube configured to deliver a medicated gel situated within that lumen.
Lonky teaches integrated drug application through an internal channel and lumen to the distal working head: “the adjuvant drug can be applied to the fenestrated loop fibers directly akin to toothpaste on a toothbrush, or a channel within the applicator can be used to transmit the drug from the top of the handle by means of a squeeze bulb or syringe, through a small lumen in the center of the fabric disc, concomitant with the tissue disruption, delivering drug into the fracture crevices created during the frictional buckling and shearing process created by the device” (Lonky, FIG. 3-4; ¶[0072]; ¶[0021]: "using an endoscope with a biopsy port"; ¶[0037]: "The platform may be... inserted through a small endoscopic channel"). In context, the quoted “channel… through a small lumen” describes a separate delivery conduit (distinct from the that of the endoscope) that receives medication at the proximal handle (via bulb/syringe) and routes it distally through the instrument to the applicator head, i.e., a delivery tube situated within the sheath’s lumen. The “akin to toothpaste on a toothbrush” language evidences a viscous, gel-like medication, supporting that the delivered medication is a medicated gel (conceptual equivalence).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Jensen in view of Lonky to provide a delivery tube routed within the established sheath lumen to deliver a medicated gel to the distal working region. The combination would have been feasible because Shadduck already provides an axially extending sleeve/lumen sized to co-locate elongated components, and Lonky teaches routing drug through an internal channel and small lumen from a proximal actuator to a distal head; incorporating this delivery tube within the endoscopic sheath is a routine packaging choice in endoscopic sheaths. The benefit would be targeted, on-demand delivery of medicated gel during the procedure, improving local therapy at the treatment site, and enhancing procedural efficiency and safety.
Claims 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Kuo et al. (Kuo, Ramsay L et al. “Holmium Laser Enucleation of the Prostate (HoLEP): A Technical Update.” World journal of surgical oncology 1.1 (2003): n. pag. Web.), hereto referred as Kuo, and further in view of Jensen et al. (US-20160095646-A1), hereto referred as Jensen, and further in view of Shadduck et al. (US-20130090642-A1), hereto referred as Shadduck, and further in view of Kortenbach et al. (US-5707392-A), hereto referred as Kortenbach
Regarding claim 18, Kuo teaches a method of treating prostate tissue, the method comprising: positioning an elongated sheath such that a distal portion of the elongated sheath is proximate the prostate tissue and enucleating the prostate tissue with a laser fiber extending longitudinally with the elongated sheath (Kuo, FIG. 7; p. 4, Step 2 – Insertion of the resectoscope: “A 26–28 F continuous flow resectoscope is inserted into the urethra with the Timberlake obturator. The inner sheath, with 7 F laser fiber stabilizing catheter in place, is then locked into the resectoscope... Lastly, the 550 µ laser fiber is placed”, which teaches positioning the continuous flow resectoscope sheath as an elongated access sheath (outer resectoscope sheath) and advancing the laser fiber through the sheath system such that the laser fiber extends longitudinally within and along the elongated sheath; Kuo, p. 6, Table 2: “26 to 28 F continuous flow resectoscope sheath with modified inner sheath (containing laser fiber stabilizing bridge)”, further evidencing a sheath architecture configured to stabilize the laser fiber; p. 2, Introduction: "holmium laser enucleation of the prostate (HoLEP) combined with mechanical morcellation represents the latest refinement of the resection technique", teaches laser enucleation of the prostate with holmium:YAG laser in BPH treatment; Abstract: "HoLEP is a promising alternative for the surgical treatment of BPH which allows complete removal of intact lobes of the prostate", confirms enucleation of prostate lobes in BPH);
morcellating the prostate tissue with a tissue removal device (Kuo, p. 8, Step 12 – Morcellation: “morcellator remains the most efficient method of tissue removal following enucleation”, teaching morcellation as the follow-on removal step after enucleation; Kuo, p. 3, Background: “holmium laser enucleation of the prostate (HOLEP), combined with mechanical morcellation”, reiterating morcellation in the HoLEP workflow).
Also regarding claim 18, Kuo does not fully teach that the method comprises: retracting, with the tissue removal device, the prostate tissue proximally through an elongated sheath, the laser fiber and the tissue removal device moving together relative to the elongated sheath while the tissue removal device retracts the prostate tissue proximally through the elongated sheath.
Rather, Kuo teaches laser-fiber enucleation performed through a resectoscope sheath system and a subsequent morcellation step (Kuo, p. 4, Step 2 – Insertion of the resectoscope: “A 26–28 F continuous flow resectoscope is inserted into the urethra... the inner sheath... is then locked into the resectoscope... Lastly, the 550 µ laser fiber is placed”; Kuo, p. 8, Step 12 – Morcellation: “morcellator remains the most efficient method of tissue removal following enucleation”). However, Kuo does not expressly teach retracting prostate tissue proximally through an elongated sheath with the tissue removal device while the laser fiber remains integrated with and moves together with the tissue removal device during such retraction.
Jensen teaches a jawed end-effector in which the jaws are configured to grasp tissue and in which a laser (optical) fiber is operably coupled to a jaw member (Jensen, [0012]-[0013] and claim 4: “the sealing plates cooperate to grasp tissue therebetween... and a longitudinal-firing optical fiber operably coupled to at least one of the first jaw member or the second jaw member...”; Jensen, [0064]: “The above-described bipolar forceps embodiments may be suitable for utilization with endoscopic Surgical procedures...”; see also [0027] and FIG. 6).
Shadduck teaches a jawed tissue cutting and extraction working end adapted for tissue morcellation, including jaw members configured with RF cutting sleeves and tissue extraction channels (Shadduck, FIG. 5-6; ¶[0052]: “FIG. 6 schematically illustrates working end 640 with jaws or clamp members 642A and 642B wherein both clamp members 642A, 642B are configured with RF cutting sleeves and tissue extraction channels. The tissue extraction channels can merge into a single channel in shaft 645”; Shadduck, ¶[0053]: “The RF cutting sleeve is then reciprocated and/or rotated in the tissue Volume captured by the clamp members”).
Kortenbach teaches the well-known endoscopic technique of withdrawing a jawed instrument through a lumen while maintaining the jaws closed to retain captured tissue, stating that the endoscope includes “a narrow lumen for receiving a biopsy forceps”, the practitioner “inserts the biopsy forceps through the lumen of the endoscope”, and, “After a sample has been obtained, the practitioner and/or an assistant carefully withdraws the instrument from the endoscope while holding the actuating handle to maintain the jaws in a closed position” (Kortenbach, col. 2, ll. 9-24).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kuo in view of Jensen, Shadduck, and Kortenbach such that, during the HoLEP workflow, prostate tissue is retracted proximally through the access sheath by withdrawing a jawed tissue removal device while maintaining tissue capture, with the laser fiber integrated with and moving together with the tissue removal device during withdrawal. The combination would have been feasible because Kuo provides the sheath-based endoscopic access architecture for HoLEP and teaches both laser-fiber enucleation and subsequent morcellation with a morcellator, Jensen teaches integrating a laser (optical) fiber with a jawed tissue-engaging end-effector configured to grasp tissue in an endoscopic instrument platform, Shadduck teaches a jawed morcellation working end in which the jaws carry RF cutting sleeves and tissue extraction channels for morcellation and extraction at the working end, and Kortenbach teaches withdrawing a jawed instrument through a lumen while maintaining the jaws closed to retain and retract tissue through the lumen. The combination is implementable in a single device because the Shadduck morcellation working end corresponds to an end-effector assembly whose morcellation features (e.g., RF cutting sleeves and tissue extraction channels on the jaws) can be incorporated into and integrated with Jensen’s jawed end-effector architecture while maintaining Jensen’s endoscopic forceps actuation and distal jaw functionality, and the Jensen laser fiber can be routed to and carried by the integrated jawed working end so that the fiber and jaws move together during endoscopic withdrawal (Jensen, [0063]-[0064]; Shadduck, ¶[0052]-¶[0053]). Further, the resulting integrated instrument is compatible with Kuo’s sheath-based HoLEP access because the combined working end and its elongate member are configured for insertion and axial movement within the resectoscope sheath lumen during tissue capture, morcellation, and proximal retraction as taught by the withdrawal-through-lumen technique (Kuo, p. 4, Step 2; Kortenbach, col. 2, ll. 9-24). The benefit would be enabling coordinated proximal withdrawal of captured/morcellated prostate tissue through the sheath while maintaining the laser fiber and tissue removal working end together in a single endoscopic instrument configuration, thereby reducing instrument exchanges and improving procedural efficiency in lumen-based prostate surgery.
Regarding claim 19, the modified Kuo does not fully teach that the morcellating the prostate tissue comprises application of radio frequency energy with a bipolar morcellator. Rather, the combined art teaches enucleation of prostate tissue followed by morcellation using RF energy, but does not specify that morcellation comprises application of radio frequency energy with a bipolar morcellator.
Shadduck teaches a jawed morcellation device wherein captured tissue is resected using radio frequency on a sleeve and describes jawed working ends adapted for laparoscopic tissue morcellation with a reciprocating RF cutting sleeve; it further teaches both jaw members carry RF electrodes, providing at least two electrodes at the working end consistent with a bipolar configuration (Shadduck, Abstract; ¶[0050]; claim 59).
Jensen teaches that electrosurgical instruments may be configured to provide bipolar electrosurgical energy, establishing the bipolar modality in a jawed instrument platform (Jensen, ¶[0027]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Kuo in view of Shadduck and Jensen to perform morcellation by applying radio frequency energy with a bipolar morcellator. The combination would have been feasible because Shadduck provides a morcellation working end that already utilizes radio frequency energy and places RF electrodes on both jaws, and Jensen teaches bipolar electrosurgical configurations in jawed instruments; adapting Kuo’s morcellation step to employ a bipolar RF jawed morcellator aligns known RF cutting and electrode arrangements with the established HoLEP workflow. The benefit would be controlled bipolar energy delivery across grasped tissue during morcellation to improve cutting efficiency and hemostasis while maintaining efficient tissue capture and extraction consistent with endoscopic prostate surgery.
Response to Arguments
Objections
Applicant's arguments filed 12/22/2025, page 5, regarding the previous Objections of claim 14 has been fully considered and are persuasive. The previous Objections have been withdrawn.
35 U.S.C. §112(b)
Applicant's arguments filed 12/22/2025, page 6, regarding the previous 112(b) Rejections of claims 6, 13, and 15 have been fully considered and are persuasive. The previous 112(b) rejections have been withdrawn.
35 U.S.C. §103
Applicant's arguments filed 12/22/2025, pages 6-9, regarding the previous 103 Rejections of claims 1-2, 5, 6, 13-15, and 18-19 have been fully considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. That is, there are new grounds of rejection. Specifically:
Argument. Applicant states that the cited references “do not teach a laser fiber and a tissue engagement tool moving together proximally through an elongated sheath while the tissue engagement tool retracts tissue proximally through the elongated sheath, as claimed”.
Response. The argument is not persuasive because it is directed to the prior combination relied upon in the non-final Office Action. The Office has entered a new ground of rejection for amended claim 1 that relies on an additional reference, Kortenbach, in combination with Jensen and Shadduck (and Kuo as previously applied), to address the newly added limitation. Accordingly, Applicant’s arguments based on Jensen, Shadduck, and Kuo alone are moot to the extent they challenge the prior rejection that did not rely on Kortenbach. Further, to the extent Applicant’s argument is intended to apply to amended claim 18 and dependent claim 19, the Office has likewise entered a new ground of rejection for amended claim 18 that relies on Kortenbach in combination with Kuo, Jensen, and Shadduck to address the newly added limitation, and claim 19 is rejected with claim 18 and further in view of the additional limitation recited in claim 19.
Argument. Applicant asserts that Jensen’s jaws grasp tissue only for sealing and do not grasp tissue “for the purpose of transporting the tissue from one location to another, such as retracting tissue proximally through a sheath,” and further alleges the device seals then withdraws without taking tissue.
Response. The argument is not persuasive because the new rejections do not rely on Jensen alone for the act of retracting tissue proximally through a lumen or sheath. Jensen is relied upon for a jawed tissue engagement tool and for the laser fiber being carried with the distal end-effector. Kortenbach is relied upon for the well-known endoscopic technique of withdrawing a jawed instrument through an endoscope lumen while maintaining jaw closure to retain captured tissue. Accordingly, the combined teachings relied upon for claim 1, and for claim 18 and its dependent claim 19, teach retracting captured tissue proximally through a lumen or sheath while the distal jawed tool and the laser fiber move together relative to the sheath due to the laser fiber being carried with the distal end-effector, as set forth in the new rejections.
Argument. Applicant argues that Shadduck is silent regarding using an optical fiber and therefore provides no teaching regarding how an optical fiber can be positioned when tissue is removed through the inner sleeve.
Response. The argument is not persuasive because the Office does not rely on Shadduck to teach the optical fiber. Shadduck is relied upon for the sleeve or sheath and lumen architecture and for a jawed tissue cutting and extraction working end adapted for morcellation. Jensen is relied upon for the laser fiber structure and distal integration with the end-effector such that the fiber is carried with and moves with the distal working end. Kortenbach supplies the withdrawal-through-lumen technique. Thus, Shadduck’s lack of optical fiber discussion does not undermine the combined teachings relied upon for claim 1, claim 18, or dependent claim 19.
Argument. Applicant contends that Kuo discusses removing the laser fiber before inserting a nephroscope for morcellation and therefore does not disclose the laser fiber and morcellation instrument moving together relative to a sheath while tissue is retracted.
Response. The argument is not persuasive because Kuo is not relied upon, by itself, to teach the “move together while retracting through sheath” limitation. Kuo is relied upon for the HoLEP procedural context, including positioning a sheath for access to prostate tissue and performing laser enucleation. The newly added “move together while retracting through sheath” limitation in amended claim 18 is addressed by the combination including Jensen for the laser fiber being carried with the distal jawed working end, and Kortenbach for withdrawing a jawed instrument through a lumen while maintaining jaw closure to retain tissue, as set forth in the new rejection. Accordingly, Applicant’s critique of Kuo on the “move together” point is not responsive to the basis of the new rejection of claim 18, and claim 19 stands rejected with claim 18.
Argument. Applicant asserts that dependent claims are allowable at least by virtue of their dependency on amended independent claim 1, and defers further remarks.
Response. The argument is not persuasive. Patentability is determined on a claim-by-claim basis, and dependency alone does not establish allowability. To the extent dependent claims are rejected, they remain rejected for the reasons set forth in the Office Action and as updated in view of the amended base claim and the new grounds of rejection, including the rejection of amended claim 18 and dependent claim 19.
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.
Any inquiry concerning this communication or earlier communications from the
examiner should be directed to AARON MERRIAM whose telephone number is (703) 756-
5938. The examiner can normally be reached M-F 8:00 am - 5:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing
using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is
encouraged to use the USPTO Automated Interview Request (AIR) at
http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
supervisor, Jason Sims can be reached on (571)272-4867. The fax phone number for the
organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained
from Patent Center. Unpublished application information in Patent Center is available to
registered users. To file and manage patent submissions in Patent Center, visit:
https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for
more information about Patent Center and https://www.uspto.gov/patents/docx for
information about filing in DOCX format. For additional questions, contact the Electronic
Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO
Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/AARON MERRIAM/Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791