DETAILED ACTION
The following is a Non-Final Office Action on the merits.
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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Response to Amendment
Acknowledgment is made to the amendment received 3/17/2026.
Applicant’s amendments are sufficient to overcome the claim objections set forth in the previous office action.
Claim Objections
Claim 25 is objected to because of the following informalities: amend “energy” to -the ablative energy- in ll. 3. Appropriate correction is required.
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 21 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 21 recites the limitation “the source of ablative energy includes an electrocautery probe comprising one or more electrodes configured to be advanced along an inner lumen of the sheath to a tissue treatment site in a narrow profile configuration and expand to a wide profile configuration when placed at the tissue treatment site to cauterize the tissue”; however, claim 11, upon which claim 21 depends, recites the limitation “a probe comprising a source of ablative energy and at least one opening in proximity to the source of ablative energy such that the source of ablative energy is configured to emit ablative energy through the at least one opening”. The originally filed disclosure fails to provide support for a probe that performs both these limitations.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 11 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 11 recites the limitation “the source of ablative energy includes an electrocautery probe comprising one or more electrodes configured to be advanced along an inner lumen of the sheath to a tissue treatment site in a narrow profile configuration and expand to a wide profile configuration when placed at the tissue treatment site to cauterize the tissue”; however, claim 11, upon which claim 21 depends, recites the limitation “a probe comprising a source of ablative energy and at least one opening in proximity to the source of ablative energy such that the source of ablative energy is configured to emit ablative energy through the at least one opening”. It is unclear how a probe can both emit ablative energy through the opening while also comprising electrodes expandable to a wide profile configure to cauterize tissue.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 11-16, 24-25 & 28-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Swarup et al. (2009/0088775, previously cited) in view of Zerfas et al. (2013/0131445) and Farkas (6,450,949, previously cited).
Concerning claim 11, as illustrated in at least Figs. 2A-C Swarup et al. disclose an apparatus to treat tissue of a patient (robotic surgical manipulator 152; [0059]), comprising:
a sheath having a proximal end and a distal end (robotic system 100 comprises hollow cannula 219 through which an electro-robotic surgical tool 101 may be inserted, where hollow cannula 219 is capable of being inserted into a patient; [0071], Fig. 1-2B);
a probe comprising a source of ablative energy, wherein the sheath and probe are configured to be inserted into the patient (robotic electro-surgical tools 101 transfer energy from generator 102 to tool 101, where cannula 219 and tool 101 are configured to be inserted into the patient; [0058], [0063]);
an element configured to lock the sheath to a lockable arm when the probe has been inserted into the patient (cannula 219 may be releasably coupled to robotic arm 153; [0071]);
a handpiece coupled to the probe, the handpiece comprising a linkage, the linkage comprising a first gear and a moveable carriage; wherein the linkage is sized to fit within the handpiece and move the source of ablative energy; (protective covers 206, 208, taken to be handpieces, and extend over linkage structure 156/212 driven by motors 217 that mechanically transfer motion via pulleys, cables, gears, links, cams, cam followers, and the like to drive electrosurgical tool 101, where all elements are coupled together; [0065], [0070]) and
wherein the ablative energy source is configured to move relative to the handpiece in response to motion of the first gear and the moveable carriage (motion is transferred to electro-surgical robotic surgery tool 101A relative to protective covers 206, 208; [0065], [0070]).
Swarup et al. fail to disclose the probe comprising at least one opening in proximity to the source of ablative energy such that the source of ablative energy is configured to emit ablative energy through the at least one opening. However, Zerfas et al. disclose a probe (100) comprising at least one opening (302c // or // 302d) in proximity to a source of ablative energy (310) such that the source of ablative energy (310) is configured to emit ablative energy through the at least one opening (302c // or // 302d). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the probe of Swarup et al. with the probe of Zerfas et al. such that the probe comprising at least one opening in proximity to the source of ablative energy such that the source of ablative energy is configured to emit ablative energy through the at least one opening in order to provide the benefit of both separating a target tissue from the body and also breaking it into smaller pieces as taught by Zerfas et al. ([0026], [0042-0043], [0045], [0052-0054], [0058]; Fig. 1-4)
While Swarup et al. disclose the sheath (219) being releasably coupled to robotic arm (153) via housing (401) ([0071]), Swarup et al. fail to disclose a protrusion on the proximal end of the sheath, the protrusion configured to lock the sheath to the lockable arm when the probe has been inserted into the patient. However, Farkas et al. disclose an apparatus comprising a protrusion (18) on a proximal end of a sheath (16) that receives a probe (14), the protrusion (18) configured to lock the sheath (16) to a housing (12) when the probe (14) is inserted to tissue. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the sheath of Swarup et al. to further comprise a protrusion configured to lock the sheath to the lockable arm when the probe has been inserted into the patient in order to provide a coupling that detachably secures the housing to the cannula as taught by Farks et al. (Col. 3, ll. 42-54; Fig. 2)
Concerning claim 12, Zerfas et al. further disclose the probe (100) comprising an opening (302c) to couple to a source of irrigation fluid (312) and an endoscope (306) viewing window (302a) are located proximal to the source of ablative energy (310) when the source is extended out of opening (302d) to urge ablated material away from the endoscope viewing window (302a) and a tissue treatment site toward the at least one opening (302d) to remove ablated material via suction device (308) and provide visibility of the surgical site to the endoscope (306) when the tissue is ablated ([0042-0043], [0052-0054], [0058]; Fig. 3B).
Concerning claim 13, Swarup et al. disclose the lockable arm (153) coupled to the sheath (219) to support the sheath (219) when placed in the patient ([0071]; Fig. 2C-D).
Concerning claim 14, Zerfas et al. further disclose the at least one opening (302c // or // 302d) configured to be advanced with the probe (100) itself (Fig. 1-4). Swarup et al. disclose the probe (101) configured to be advanced through the sheath (219) and rotated and translated when the lockable arm (153) is in a locked configuration with the probe (101) inserted into a urethra of the patient ([0059], [0061], [0065], [0068-0071]; Fig. 1-2B). Thus, the modified invention of Swarup et al. in view of Zerfas et al. disclose the at least one opening of the probe configured to be advanced through the sheath and orated and translated when the lockable arm is in a locked configuration with the probe inserted into a urethra of the patient.
Concerning claim 15, Swarup et al. disclose a processor (151/302) configured to cause a reference location to be displayed on display (153), wherein the probe (101) and the lockable arm (153) are coupled to the linkage (156, 158, 212) to reference a treatment of the patient to the reference location when the probe (101) has been placed in the patient without an anchor on a distal end of the probe (101) ([0004], [0065], [0068], [0070], [0098-0099], [0212-0214]).
Concerning claim 16, Swarup et al. disclose a docking mechanism (releasable coupling) on the arm (153) configured to couple to the proximal end of the sheath (219) to engage the sheath (219) with the lockable arm (153) and lock the sheath (219) to the arm (153) when the probe (210) has been inserted into the patient ([0065-0068]; Fig. 2B). Farkas et al. disclose a docking mechanism (receiving portion of housing 12 for bayonet coupling) to be on a distal end of the housing (12) (Fig. 12). Thus, the modified invention of Swarup et al. in view of Zerfas et al. disclose the docking mechanism on a distal end of the lockable arm configured to couple to the protrusion on the proximal end of the sheath to engage the sheath with the lockable arm and lock the sheath to the lockable arm when the probe has been inserted into the patient.
Concerning claim 24, Swarup et al. disclose the sheath (219) comprises a stiff sheath as compared to soft tissue ([0071]).
Concerning claim 25¸ Swarup et al. disclose the sheath (219) comprises a distal opening and the probe (101) and sheath (219) are sized for the energy source (distal tip) to extend beyond the distal opening to release energy toward the tissue ([0071]; Fig. 2B).
Concerning claim 28, Zerfas et al. further disclose the probe comprises a first channel (302c) to transfer liquid for irrigation, the first channel (302c) extending from a proximal end of the probe (100) to the distal end of the probe (100) in an orientation that is parallel with a longitudinal axis of the probe (100) ([0043]; Fig. 1-4).
Concerning claim 29, Zerfas et al. further disclose an endoscope viewing camera (306) fixedly coupled to the probe ([0048-0049]; Fig. 1-4). Thus, the modified invention of Swarup et al. in view of Zerfas et al. and Farkas et al. disclose an endoscope viewing camera fixedly coupled to the lockable arm.
Concerning claim 30, a manifold positioned at the proximal end of the sheath, the manifold comprising the protrusion.
Claim(s) 11-16 & 22-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Swarup et al. (2009/0088775, previously cited) in view of Slepian et al. (6,491,672, previously cited), Zerfas et al. (2013/0131445) and Farkas (6,450,949, previously cited).
Concerning claim 11, as illustrated in at least Figs. 2A-C Swarup et al. disclose an apparatus to treat tissue of a patient (robotic surgical manipulator 152; [0059]), comprising:
a sheath having a proximal end and a distal end (robotic system 100 comprises hollow cannula 219 through which an electro-robotic surgical tool 101 may be inserted, where hollow cannula 219 is capable of being inserted into a patient; [0071], Fig. 1-2B);
a probe comprising a source of ablative energy, wherein the sheath and probe are configured to be inserted into the patient (robotic electro-surgical tools 101 transfer energy from generator 102 to tool 101, where cannula 219 and tool 101 are configured to be inserted into the patient; [0058], [0063]);
an element configured to lock the sheath to a lockable arm when the probe has been inserted into the patient (cannula 219 may be releasably coupled to robotic arm; [0071]);
a handpiece comprising a linkage, the linkage comprising a first gear and a moveable carriage; wherein the linkage is sized to fit within the handpiece and move the source of ablative energy; (protective covers 206, 208, taken to be handpieces, and extend over linkage structure 156/212 driven by motors 217 that mechanically transfer motion via pulleys, cables, gears, links, cams, cam followers, and the like to drive electrosurgical tool 101; [0065], [0070]) and
wherein the ablative energy source is configured to move relative to the handpiece in response to motion of the first gear and the moveable carriage (motion is transferred to electro-surgical robotic surgery tool 101A relative to protective covers 206, 208; [0065], [0070]).
Swarup et al. fail to disclose the probe comprising at least one opening in proximity to the source of ablative energy. However, Slepian et al. disclose an electrosurgical tool comprising a probe (12 or 30) comprising at least one opening (any of openings at distal end of 12 or 30) in proximity to a source of ablative energy (cold-knife or radio-frequency cutter 26 or cutter 16, 40 or 50). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the probe of Swarup et al. with the probe of Slepian et al. such that the probe comprises at least one opening in proximity to the source of ablative energy in order to provide the benefit of transporting fluid in either direction to facilitate the cutting process as taught by Slepian et al. (Col. 7, ll. 14-22 & 32-54)
While Slepian et al. disclose the source of ablative energy (cold-knife or radio-frequency cutter 26 or cutter 16, 40 or 50) can be deployed form the opening (any of openings at distal end of 12 or 30), Slepian et al. fail to specifically disclose the source of ablative energy configured to emit ablative energy through the at least one opening. However, Zerfas et al. disclose a probe (100) comprising at least one opening (302c // or // 302d) in proximity to a source of ablative energy (310) such that the source of ablative energy (310) is configured to emit ablative energy through the at least one opening (302c // or // 302d). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the source of ablative energy of Swarup et al. in view of Slepian et al. with the source of ablative energy of Zerfas et al. such that the probe comprising at least one opening in proximity to the source of ablative energy such that the source of ablative energy is configured to emit ablative energy through the at least one opening in order to provide the benefit of both separating a target tissue from the body and also breaking it into smaller pieces as taught by Zerfas et al. ([0026], [0042-0043], [0045], [0052-0054], [0058]; Fig. 1-4) and since the source of ablative energy of Zerfas et al. is considered an equivalent in the art for the purposes of tissue cutting.
While Swarup et al. disclose the sheath (219) being releasably coupled to robotic arm (153) via housing (401) ([0071]), Swarup et al. fail to disclose a protrusion on the proximal end of the sheath, the protrusion configured to lock the sheath to the lockable arm when the probe has been inserted into the patient. However, Farkas et al. disclose an apparatus comprising a protrusion (18) on a proximal end of a sheath (16) that receives a probe (14), the protrusion (18) configured to lock the sheath (16) to a housing (12) when the probe (14) is inserted to tissue. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the sheath of Swarup et al. in view of Slepian et al. and Zerfas et al. to further comprise a protrusion configured to lock the sheath to the lockable arm when the probe has been inserted into the patient in order to provide a coupling that detachably secures
Concerning claim 12, Slepian et al. further disclose the probe (12 or 30) comprising an opening (22 or 38) to couple to a source of irrigation fluid and an endoscope viewing window (14 or 34) are located proximal to the source of ablative energy (16/26/40/50) to urge ablated material away from the endoscope viewing window (14 or 34) and a tissue treatment site toward the at least one opening (38 or 22) to remove ablated material and provide visibility of the surgical site to the endoscope when the tissue is ablated (Col. 6-7, ll. 45-22; Fig. 2-3).
Concerning claim 13, Swarup et al. disclose the lockable arm (153) coupled to the sheath (219) to support the sheath (219) when placed in the patient ([0071]; Fig. 2C-D).
Concerning claim 14, Slepian et al. further disclose the at least one opening (38 or 22) configured to be advanced with the probe (12 or 30) itself (Fig. 2-3). Swarup et al. disclose the probe (101) configured to be advanced through the sheath (219) and rotated and translated when the lockable arm (153) is in a locked configuration with the probe (101) inserted into a urethra of the patient ([0059], [0061], [0065], [0068-0071]; Fig. 1-2B). Thus, the modified invention of Swarup et al. in view of Slepian disclose the at least one opening of the probe configured to be advanced through the sheath and orated and translated when the lockable arm is in a locked configuration with the probe inserted into a urethra of the patient.
Concerning claim 15, Swarup et al. disclose a processor (151/302) configured to cause a reference location to be displayed on display (153), wherein the probe (101) and the lockable arm (153) are coupled to the linkage (156, 158, 212) to reference a treatment of the patient to the reference location when the probe (101) has been placed in the patient without an anchor on a distal end of the probe (101) ([0004], [0065], [0068], [0070], [0098-0099], [0212-0214]).
Concerning claim 16, Swarup et al. disclose a docking mechanism (releasable coupling) on the arm (153) configured to couple to the proximal end of the sheath (219) to engage the sheath (219) with the lockable arm (153) and lock the sheath (219) to the arm (153) when the probe (210) has been inserted into the patient ([0065-0068]; Fig. 2B). Farkas et al. disclose a docking mechanism (receiving portion of housing 12 for bayonet coupling) to be on a distal end of the housing (12) (Fig. 12). Thus, the modified invention of Swarup et al. in view of Slepian et al. and Zerfas et al. disclose the docking mechanism on a distal end of the lockable arm configured to couple to the protrusion on the proximal end of the sheath to engage the sheath with the lockable arm and lock the sheath to the lockable arm when the probe has been inserted into the patient.
Concerning claim 22, Slepian et al. further disclose the probe (30) comprises an intermediate carrier (32), the intermediate carrier (32) comprising a first channel (34) to receive an endoscope and a second channel (36) sized to receive a carrier of a source of ablative energy (40), the first channel (34) extending along a central axis of the intermediate carrier (32) in order to rotate the second channel (36) and the source of ablative energy (40) around the first channel (34) to view the treatment site with the endoscope (Fig. 3 as 32 can be rotated around axis within 34) (Fig. 3).
Concerning claim 23, Slepian et al. further disclose an elongate sliding support (interior of lumen 34) configured to couple an endoscope to the sheath (Swarup: 219) (Col. 7, ll. 14-54; Fig. 3).
Concerning claim 24, Swarup et al. disclose the sheath (219) comprises a stiff sheath as compared to soft tissue ([0071]).
Concerning claim 25¸ Swarup et al. disclose the sheath (219) comprises a distal opening and the probe (101) and sheath (219) are sized for the energy source (distal tip) to extend beyond the distal opening to release energy toward the tissue ([0071]; Fig. 2B).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over by Swarup et al. (2009/0088775, previously cited) in view of Slepian et al. (6,491,672, previously cited), Zerfas et al. (2013/0131445) and Farkas (6,450,949, previously cited) or Swarup et al. (2009/0088775, previously cited) in view of Zerfas et al. (2013/0131445) and Farkas (6,450,949, previously cited), as applied to claim 11, in further of Desai (2003/0130575, previously cited) and Kato (6,354,992, previously cited).
Concerning claim 17, Swarup et al. in view of Zerfas et al. and Farkas or Swarup et al. in view of Slepian et al., Zerfas et al. and Farkas fail to disclose a second sheath disposed over at least a portion of a TRUS probe, the second sheath comprising stiffness to decrease movement of tissue when the TRUS probe is moved axially within the second sheath. However, Desai discloses an apparatus to treat tissue comprising a TRUS probe. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the apparatus of Swarup et al. in view of Zerfas et al. and Farkas or Swarup et al. in view of Slepian et al., Zerfas et al. and Farkas to further comprise a TRUS probe in order to provide the benefit of accessing the prostate transrectally as taught by Desai ([0096]) Swarup et al. in view of Zerfas et al. and Farkas or Swarup et al. in view of Slepian et al., Zerfas et al. and Farkas, in further view of Desai fail to disclose a second sheath disposed over at least a portion of the TRUS probe, the second sheath comprising stiffness to decrease movement of tissue when the TRUS probe is moved axially within the second sheath. However, Kato discloses a second sheath (30) disposed over at least a portion of an ultrasound probe (300) probe, the second sheath (30) comprising stiffness (rigid hollow split sheath) to decrease movement of tissue when the ultrasound probe (300) is moved axially within the second sheath (30). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the apparatus of Swarup et al. in view of Swarup et al. in view of Zerfas et al. and Farkas or Swarup et al. in view of Slepian et al., Zerfas et al. and Farkas, in further view of Desai to further comprise a second sheath disposed over at least a portion of the TRUS probe, the second sheath comprising stiffness to decrease movement of tissue when the TRUS probe is moved axially within the second sheath in order to provide the benefit of cleaning the imaging lens as taught by Kato. (Col. 1, ll. 60-67, Col. 2, ll. 26-49, Col. 3-4, ll. 44-59; Fig. 3)
Claim(s) 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Swarup et al. (2009/0088775, previously cited) in view of Slepian et al. (6,491,672, previously cited), Zerfas et al. (2013/0131445) and Farkas (6,450,949, previously cited) or Swarup et al. (2009/0088775, previously cited) in view of Zerfas et al. (2013/0131445) and Farkas (6,450,949, previously cited), as applied to claim 11, in further of Desai (2003/0130575, previously cited) and Ranalletta et al. (5,437,283, previously cited).
Concerning claim 17, Swarup et al. in view of Zerfas et al. and Farkas or Swarup et al. in view of Slepian et al., Zerfas et al. and Farkas fail to disclose a second sheath disposed over at least a portion of a TRUS probe, the second sheath comprising stiffness to decrease movement of tissue when the TRUS probe is moved axially within the second sheath. However, Desai discloses an apparatus to treat tissue comprising a TRUS probe. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the apparatus of Swarup et al. in view of Zerfas et al. and Farkas or Swarup et al. in view of Slepian et al., Zerfas et al. and Farkas to further comprise a TRUS probe in order to provide the benefit of accessing the prostate transrectally as taught by Desai ([0096]) Swarup et al. in view of Zerfas et al. and Farkas or Swarup et al. in view of Slepian et al., Zerfas et al. and Farkas, in further view of Desai fail to disclose a second sheath disposed over at least a portion of the TRUS probe, the second sheath comprising stiffness to decrease movement of tissue when the TRUS probe is moved axially within the second sheath. However, Ranalletta et al. discloses a second sheath (140/154/160/172/184) disposed over at least a portion of an ultrasound probe (170), the second sheath (140/154/160/172/184) comprising stiffness to decrease movement of tissue when the ultrasound probe (170) is moved axially within the second sheath (140/154/160/172/184). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the apparatus of Swarup et al. in view of Zerfas et al. and Farkas or Swarup et al. in view of Slepian et al., Zerfas et al. and Farkas, in further view of Desai to further comprise a second sheath disposed over at least a portion of the TRUS probe, the second sheath comprising stiffness to decrease movement of tissue when the TRUS probe is moved axially within the second sheath in order to provide the benefit of reducing the need for extensive sterilization of the TRUS probe and the ability to use ultrasonically transmissive material without having to coat the TRUS probe before ultrasonic coupling as taught by Ranalletta et al.. (Col. 4, ll. 51-58, Col. 5, ll. 1-26, Col. 16-18, ll. 12-29; Fig. 9A-15)
Concerning claim 18¸Ranalletta et al. further disclose the second sheath (140/154/160/172/184) comprises a closed end to inhibit deposition of fecal matter between a distal end of the TRUS probe (170) and a distal end of the stiff sheath (140/154/160/172/184) (Col. 16-18, ll. 12-29; Fig. 9A-15).
Concerning claim 19, Ranalletta et al. further disclose a container (inherent as at some point the coupling fluid is contained before it is put into the sheath) coupled to an interior chamber (162/188) defined with the second sheath (140/154/160/172/184) and the distal end of the TRUS probe (170) to receive ultrasound coupling fluid from the interior chamber (162/188) when the TRUS probe (170) is advanced distally and to provide fluid to the interior chamber (162/188) when the TRUS probe (170) is drawn proximally (Col. 16-18, ll. 12-29; Fig. 9A-15).
Concerning claim 20¸Ranalletta et al. further disclose an inner diameter (at sealing device 166/180) of the second sheath (140/154/160/172/184) approximates an outer diameter of the TRUS probe (170) to inhibit coupling fluid from passing along a space between the inner surface and the outer surface (Col. 16-18, ll. 12-29; Fig. 9A-15).
Claim(s) 26-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Swarup et al. (2009/0088775, previously cited) in view of Slepian et al. (6,491,672, previously cited), Zerfas et al. (2013/0131445) and Farkas (6,450,949, previously cited) or Swarup et al. (2009/0088775, previously cited) in view of Zerfas et al. (2013/0131445) and Farkas (6,450,949, previously cited), as applied to claim 11, in further of Bednarek et al. (6,120,500, previously cited).
Concerning claim 26, Swarup et al. in view of Zerfas et al. and Farkas or Swarup et al. in view of Slepian et al., Zerfas et al. and Farkas fail to disclose a spine to add stiffness to the sheath, wherein the spine extends beyond a distal opening of the sheath. However, Bednarek et al. disclose an apparatus comprising a spine (16) to add stiffness to a sheath (14), wherein the spine (16) extends beyond a distal opening of the sheath (14). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the probe of Swarup et al. in view of Zerfas et al. and Farkas or Swarup et al. in view of Slepian et al., Zerfas et al. and Farkas to further comprise a spine to add stiffness to the sheath, wherein the spine extends beyond a distal opening of the sheath in order to provide the benefit of providing a guide and support such that the spine is flexible enough to not injure the tissue surface while still retaining sufficient structural integrity to support the probe to perform the procedure as taught by Bednarek et al. (Col. 6, ll. 9-42, Col. 7, ll. 7-19, Col. 7-8, ll. 63-6, Col. 8-9, ll. 57-5; Fig. 9)
Concerning claim 27, Swarup et al. in view of Zerfas et al. and Farkas or Swarup et al. in view of Slepian et al., Zerfas et al. and Farkas fail to disclose a spine, the sheath located around the spine, the spine coupled to a manifold and the sheath to add stiffness to the sheath. However, Bednarek et al. disclose a spine (16), a sheath (14) located around the spine (16), the spine (16) indirectly coupled to a manifold (proximal end connectors) and the sheath (14) to add stiffness to the sheath (14). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the probe of Swarup et al. in view of Zerfas et al. and Farkas or Swarup et al. in view of Slepian et al., Zerfas et al. and Farkas to further comprise a spine, the sheath located around the spine, the spine coupled to a manifold and the sheath to add stiffness to the sheath in order to provide the benefit of providing a guide and support such that the spine is flexible enough to not injure the tissue surface while still retaining sufficient structural integrity to support the probe to perform the procedure as taught by Bednarek et al. (Col. 6, ll. 9-42, Col. 7, ll. 7-19, Col. 7-8, ll. 63-6, Col. 8-9, ll. 57-5; Fig. 9)
Response to Arguments
Applicant’s arguments have been 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAYMI E DELLA whose telephone number is (571)270-1429. The examiner can normally be reached on M-Th 6:00 am - 4:45 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, Joanne Rodden can be reached on (303) 297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JAYMI E DELLA/Primary Examiner, Art Unit 3794
JAYMI E. DELLA
Primary Examiner
Art Unit 3794
Prosecution Insights