Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Arguments
Applicant's arguments filed 06/30/2026 have been fully considered but they are not persuasive.
Response to Arguments
Applicant's arguments filed 06/30/2026 with respect to the rejections made under 35 U.S.C. §102 have been fully considered but they are not persuasive.
On page 5 of 7, last line through page 6 of 7, line 3 Applicant asserts:
“Applicant respectfully submits that Belson does not teach or suggest at least this subject matter of amended claim 1, as discussed during the interview. For example, the alleged shaft of Belson, elongate body 103, does not extend linearly between a distal end to the proximal end. See, e.g., Belson at FIG. 17.”
The examiner disagrees. As shown in the reproduction of figure 17 below there is a linear extension of the shaft between the proximal end of the shaft and the distal end of the shaft.
[AltContent: textbox (θ , theta direction)][AltContent: textbox (Linear extension disposed between the distal and proximal ends)]
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[AltContent: arrow][AltContent: arrow][AltContent: arrow][AltContent: textbox (R, Radial direction)][AltContent: textbox (z, longitudinal Radial direction)][AltContent: arrow][AltContent: ][AltContent: arrow][AltContent: arrow]
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There is also a much shorter linear extension of the shaft located between the proximal end of the shaft and the distal end of the shaft adjacent the section of the shaft (“body 103”) adjacent “ring 152” (see reproduced figure 17 above).
Next on page 6 of 7, line 3-5, Applicant asserts:
“Belson does not teach or suggest at least one energy source on the shaft configured to deliver energy radially outwardly from a side of the probe.”
Again, the examiner disagrees. As shown in the rejections below a cylindrical coordinate system is provided with cylindrical coordinates z, r, and θ (theta), where z is the longitudinal coordinate, r is the radial coordinate and θ is the angular coordinate. Since Belson discloses many species wherein the energy propagates out of the distal end the propagation has a radial component when there is a bend in the distal end – as shown in the reproduced figure 17 above.
Applicant’s traversal of the obviousness rejections (see page 6 of 7, last four full paragraphs rely on to two traversals for the anticipation rejections that were successfully rebutted above. Therefore, these traversals are also rebutted.
Accordingly, this action is made FINAL.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 1, 3-10, and 16-20 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Belson (U.S. Patent Application Publication 2007/0135803).
Regarding claim 1, Belson discloses a device comprising:
a shaft having a proximal end (“the proximal end 111,” see [0220] and figure 17) and a distal end (the distal end of “selectively steerable distal portion 105,” see [0223] and figure 17), the shaft extending linearly between the proximal end and the distal end (there is: 1) a first linear extension of the shaft between the proximal end of the shaft and the distal end of the shaft, and 2) a much shorter linear extension of the shaft located between the proximal end of the shaft and the distal end of the shaft adjacent the section of the shaft (“body 103”) adjacent “ring 152” (see reproduced figure 17 above);
at least one energy source positioned in an energy delivery region on the shaft configured to deliver energy radially outwardly from a side (the distal or distal end side) of the probe (see reproduced figure 17 above with the z, r, and θ cylindrical coordinate system);
a lumen on/in the shaft configured to remove treated tissue products with aspiration ("vacuum channels," see [0241]);
a lumen ("irrigation" lumen, see [0241]) in the shaft for flushing with a fluid to help remove the treated tissue products; and
motors ("motors," see [0217], [0224], [0232]) and control circuitry (the circuitry of A) "electronic motion controller 140," and B) "controller cable 136," see [0221] and figure 17, and alternate/equivalent counterparts in other embodiments) operatively coupled to the energy source to control movements of the energy source relative to the shaft.
Regarding claim 3, Belson discloses the energy source is movable relative to the shaft to
selectively direct the energy at different regions of the tissue (see for example figure 17).
Regarding claim 4, Belson discloses the control circuitry is configured to translate (see
[0224]) and rotate (see [0233]-[0234] and figure 17) the energy source relative to the
shaft.
Regarding claims 5-6, Belson discloses 1) an expandable anchor near the distal end for
anchoring in a bladder ("balloon," see [0208], [[0488]-[0489]), and 2) the expandable
anchor comprises a balloon adopted to expand to occupy an interior of the bladder
when it is inflated ("balloon," see [0208], [[0488]-[0489]).
Regarding claim 7, Belson discloses the energy source comprises a laser energy source
("laser" output or similar element, see [0207] and [0757], and alternate/equivalent
counterparts in other embodiments, see [0757]).
Regarding claim 8, Belson discloses the energy source further comprises a mirror for
reflecting laser energy from the laser energy source (the optical fibers having cladding
that forms a cylindrical mirror, see [0232, [0323]).
Regarding claim 9, Belson discloses the energy source comprises a conductive fluid
("water" and/or "saline," see [0423]) source and a radiofrequency energy source ("RF
knife," see [0214], [0757]).
Regarding claim 10, Belson discloses the energy source comprises an electrode ("RF
knife," see [0214], [0757]).
Regarding claims 16-17, Belson discloses the motors and control circuitry are
configured to operatively control a rotational (see [0233]-[0234] and figure 17) and a
translational(see [0224]) movement of the energy source, wherein the rotational and the
translational movement are separately controlled (since the motors are separate motors
and they are controlled separate, see [0224] and [0233]-[0234]).
Regarding claim 18, Belson discloses the rotational and the translational movement are
controlled accordingly to axial and rotational movement parameters according to a treatment protocol (see the various "treatments" for particular organs in [0211 ]-[0213] for example and consider that the distal end of the endoscope, for example, must be properly placed).
Regarding claim 19, Belson discloses the energy of the energy source is controlled accordingly to a treatment protocol (see the various "treatments" for particular organs in
[0211 ]-[0213] for example and consider that the distal end of the endoscope, for example, must be properly placed before the energy is delivered to the target tissue).
Regarding claim 20, Belson discloses treatment protocol includes an amount of energy
released by the energy source (see the various "treatments" for particular organs in
[021 l]-[0213] for example and consider that the appropriate amount of energy, for
example, must be applied in order to achieve the desired effect on the desired target
tissue).
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 2 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Belson (U.S.
Patent Application Publication 2007 /0135803) as applied to claim 1 above, and further in view of case law - change of size.
Regarding claim 2, Belson shows the invention above including disclosing "the
endoscope 100 is typically from 135 to 185 cm in length and approximately 12-13 mm in
diameter" (see [0219]).
So Belson fails to explicitly recite the shaft has a width in the range from 1 mm to 10 mm and a length in the range from 15cm to 25cm.
However, it would have been an obvious matter of design choice to provide the shaft with a width in the range from 1 mm to 10 mm and a length in the range from 15cm to 25cm, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Therefore, at the time of the of invention it would have been obvious to one of ordinary skill in the art to modify the invention of Belson, as taught by the case law of In re Rose, to change the width or diameter of the endoscope shaft to a value in the range of 1 mm to 10 mm and change to shaft endoscope length of a value in the range of 15cm to 25cm, particularly if the patient is small (e.g., a child or infant).
Claims 11-15 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Belson (U.S. Patent Application Publication 2007/0135803) as applied to claim 1 above, and further in view of Manzo et al. (U.S. Patent Application Publication 2008/0046122).
Regarding claims 11-15, Belson shows the invention above,
but fails to explicitly recite:
A) a robotic arm, the energy source coupled to the robotic arm { claim 11};
B) a control system, wherein the control system is configured to move the robotic arm { claim 12};
C) the control system is configured to guide the arm via input from an input device { claim 13};
D) the input device is a manipulator { claim 14}; and
E) the control system comprises the control circuitry { claim 15}.
Like Belson, Manzo et al. disclose a endoscopic surgical system having an energy source positioned in an energy delivery region on a shaft and teach providing the system with A) a robotic arm (one of the "robotic surgical arms 153," see [0059] and figures l-2B) attached to a complete robotic system having B) a control system (comprising "master control console 150" and "robotic surgical manipulator 152," see [0053] and figure 1), wherein the control system is configured to move the robotic arm, C) the control system is configured to guide the arm via input from an input device ("input devices," see [0053]), D) wherein the input device is a manipulator ("input devices," see [0053], also see figures 3A-3C), and E) the control system comprises the control circuitry ("integrated circuits 426," see [0080]) in order to provide a known and workable manner of robotically controlling the endoscope and surgical procedure.
Therefore, at the time of the of invention it would have been obvious to one of ordinary skill in the art to modify the invention of Belson, as taught by Manzo et al., to providing the system with A) a robotic arm attached to a complete robotic system having B) a control system, wherein the control system is configured to move the robotic arm, C) the control system is configured to guide the arm via input from an input device, D) wherein the input device is a manipulator, and E) the control system comprises the control circuitry in order to provide a known and workable manner of robotically controlling the endoscope and surgical procedure.
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 F ROANE whose telephone number is (571)272-4771. The examiner can normally be reached generally Mon-Fri 8am-9pm.
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, Niketa Patel can be reached at (571) 272-4156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AARON F ROANE/Primary Examiner, Art Unit 3792