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 .
This action is in response to the amendment filed on 01/29/2026. Claims 1-5 and 7-26 are pending. Claims 1 and 16 are independent. Claims 6 and 27-34 are canceled.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Currently, none of the claim limitations are interpreted under 35 U.S.C. 112(f).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-4 and 7-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Truckai (US Pub. No.: 2017/0056055) in view of Hashimshony et al. (US Pub. No.: 2008/0039742).
Regarding claims 1-4 and 7-12, Truckai discloses [claim 1] a medical system (100, Figs. 1 and 2) for resecting tissue in a body of a patient, comprising: a probe (105, Fig. 1) having an elongated shaft assembly (110, Fig. 1) extending about a longitudinal axis (longitudinal axis of 110 runs through the entire 110 in the longitudinal direction of 110, Fig. 1) to a working end (112, Figs. 1 and 2; alternatively, the combination of 112 and 260, Fig. 3C and Para. [0044]), where the working end is adapted for introduction into a site in an interior of an organ (Fig. 3C and Para. [0043]- and [0044])); a tissue resecting component (126, Fig. 2) within the working end; an ultrasound sensor (210, Fig. 2. As described in Paras. [0008], [0009], [0016] and [0040], the sensors can be ultrasound sensors) carried by the working end; and a controller (140, Fig. 1) coupled to the tissue resecting component and the ultrasound sensor (Paras. [0037]-[0040]); where the ultrasound sensor sends imaging signals to the controller which locate a surface of the organ (Paras. [0007]-[0010], [0016], [0037]-[0040], the ultrasound sensors send visible/imaging signal to the controller which locate a surface of the organ); and where the controller in response to the imaging signals, is configured to:(i) determine a distance between the tissue resecting component and the surface of the organ (Paras. [0008], [0013], and [0040], the controller is configured to determine a distance between the tissue resecting component and the surface of the organ because it determines whether the cutting member is within a pre-determined proximity to the organ surface); (ii) allow activation of the tissue resecting component when positioned at least a selected distance from said surface of the organ (Para. [0015]; and(iii) modulate activation of the tissue resecting component when positioned at less than said selected distance from said surface of the organ (Para. [0017]); [claim 2] where the tissue resecting component comprises a mechanical resecting device (blade 126, Fig. 2); [claim 3] where the controller is configured to de-activate the tissue resecting component (Para. [0017]); [claim 4] where the controller is configured to slow a movement of a mechanical resecting device (Para. [0017]); [claim 7] where the tissue resecting component comprises a first sleeve (115, Fig. 2 and Para. [0035]) and a second sleeve (125, Fig. 2 and Para. [0035]) concentrically located where the first sleeve has a tissue-receiving window (118, Fig. 2 and Para. [0035]) and the second sleeve is moveable to resect tissue received in the tissue-receiving window (Para. [0035]); [claim 8] where the second sleeve is motor driven (Paras. [0036]-[0040]); [claim 9] where the second sleeve is configured to move by rotation (Para. [0035]; [claim 10] a negative pressure source controlled by the controller adapted to aspirate resected tissue through the tissue resecting component and the elongated shaft assembly (Paras. [0014], [0036], and [0038]); [claim 11] a fluid source (155, Fig. 1) and Paras. [0039] and [0044]) controlled by the controller for controlling a fluid inflow to the site; and [claim 12] where the controller is configured to control at least one of negative pressure source and the fluid source to control fluid pressure in the site (Paras. [0014], [0036]-[0044]). However, Truckai does not specifically disclose that the ultrasound sensor is configured to propagate sound waves axially and angularly relative to the longitudinal axis of the elongated shaft assembly.
Hashimshony teaches, in the same field of endeavor (system for resecting tissue), an ultrasound sensor (38, Fig. 2a and 3) carried by a working end of a probe (45, Figs. 2a and 3), where the ultrasound sensor is configured to propagate sound waves (58, Fig. 3) axially and angularly relative to the longitudinal axis of the elongated shaft assembly (Fig. 3).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the ultrasound sensor of system of Truckai to be configured to propagate sound waves axially and angularly relative to the longitudinal axis of the elongated shaft assembly as taught by Hashimshony in order to calculate the distances from the probe to the reflecting boundaries of the target (Hashimshony, Para [0015]) and/or reducing the instrumentation dead time (Hashimshony, Para. [0231]).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Truckai (US Pub. No.: 2017/0056055) in view of Hashimshony et al. (US Pub. No.: 2008/0039742) as applied to claim 1 above, and further in view of Weng et al. (US Pat. No.: 6,626,855).
Regarding claim 5, Truckai in view of Hashimshony discloses substantially all the limitations of the claim as taught above but fails to disclose that the ultrasound sensor uses a frequency ranging from 2 MHz to 10 MHz.
Weng teaches, in the same field of endeavor (ultrasound imaging/sensor), an ultrasound sensor using a frequency ranging from 2 MHz to 10 MHz, such as 2 MHz (Col. 2, lines 6-14).
Before the effective filing date of the claimed invention, it would have been obvious to modify the ultrasound sensor of the system of Truckai in view of Hashimshony to use a frequency ranging from 2 MHz to 10 MHz. such as 2 MHz, as taught by Weng, since it has been held that where the general conditions of a clam are disclosed in the prior art, discovering the optimum or workable range involves only routine skill in the art. See MPEP 2144.05.
Claim(s) 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Truckai (US Pub. No.: 2017/0056055) in view of Hashimshony et al. (US Pub. No.: 2008/0039742) as applied to claim 11 above, and further in view of Jezierski et al. (US Pub. No.: 2017/0049952).
Regarding claims 13-15, Truckai in view of Hashimshony discloses all the limitations of claim 11 but fails to disclose that [claim 13] where the controller is configured to maintain a selected set pressure in the site; [claim 14] where the controller is configured to adjust a set selected pressure in response to an operating condition; [claim 15] where the operating condition is at least one of (i) a volume of resected tissue, (ii) a number of times the controller de-activated the tissue resecting component, (iii) a change in sensed pressure in the site, (iv) a rate of change of sensed pressure in the site, and (v) total time of activation of the tissue resecting component.
Jezierski teaches, in the same field of endeavor (medical system having controller for controlling fluid pressure in the surgical site), a controller (102a, Para. [0075]) configured to maintain a selected set pressure in the site; where the controller is configured to adjust a set selected pressure in response to an operating condition (Paras. [0075] and [0080]-[0082]); where the operating condition is a change in sensed pressure in the site (Paras. [0075] and [0080]-[0082]).
Before the effective filing date of the claimed invention, it would have been obvious to modify the controller of the system of Truckai in view of Hashimshony to be configured to maintain a selected set pressure in the site; where the controller is configured to adjust a set selected pressure in response to an operating condition; where the operating condition is a change in sensed pressure in the site as taught by Jezierski in order to obtain the advantage of maintaining desired operational condition to facilitate the surgical operation (Jezierski, Para. [0074], [0091], and [0093]).
Claim(s) 16 and 19-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Truckai (US Pub. No.: 2017/0056055) in view of Hashimshony et al. (US Pub. No.: 2008/0039742) and Takikawa et al. (US Pub. No.: 2020/0315724).
Regarding claim 16, Truckai discloses [claim 16] a medical device for resecting tissue, comprising: an elongated shaft (110, Fig. 1 and 2) extending about an axis to a working end (112, Fig. 2) configured with a resecting tool (126, Fig. 2) for resecting tissue; an ultrasound sensor (210, Fig. 2. As described in Paras. [0008], [0009], [0016] and [0040], the sensors can be ultrasound sensors) carried by the elongated shaft; a controller (140, Fig. 1) operatively coupled to the resecting tool and the ultrasound sensor (Paras. [0037]-[0040]), the controller configured to calculate a limit distance comprising a distance between a tissue resecting component of the resecting tool and a surface of an organ, such that when signals from the ultrasound sensor are sent to the controller, the controller is configured to modulate activation of the tissue resecting component when positioned at less than the limit distance (Paras. [0008], [0013], [0017], and [0049]). However, Truckai does not explicitly disclose that that the ultrasound sensor is configured to propagate sound waves axially and angularly relative to the longitudinal axis of the elongated shaft assembly; and a display adapted to display ultrasound images generated from the ultrasound sensor; and a robotic mechanism coupled to the elongated shaft configured to move the resecting tool in at least one direction selected from rotationally, axially, angularly or a combination thereof.
Hashimshony teaches, in the same field of endeavor (system for resecting tissue), an ultrasound sensor (38, Fig. 2a and 3) carried by a working end of a probe (45, Figs. 2a and 3), where the ultrasound sensor is configured to propagate sound waves (58, Fig. 3) axially and angularly relative to the longitudinal axis of the elongated shaft assembly (Fig. 3).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the ultrasound sensor of system of Truckai to be configured to propagate sound waves axially and angularly relative to the longitudinal axis of the elongated shaft assembly as taught by Hashimshony in order to calculate the distances from the probe to the reflecting boundaries of the target (Hashimshony, Para [0015]) and/or reducing the instrumentation dead time (Hashimshony, Para. [0231]).
Takikawa teaches, in the same field of endeavor (medical device), a display adapted to display ultrasound images generated from the ultrasound sensor (Para. [0086], [0089], and [0090]); and a robotic mechanism (robotic arm 21 for a medical tool shown in Fig. 1) coupled to the elongated shaft fully capable to move the resecting tool in at least one direction selected from rotationally, axially, and angularly or a combination thereof (Paras. [0016] -[0019] and [0063]-[0075], robotic arm is coupled to the medical tool and thus the elongated shaft which is part of the medical tool).
Before the effective filing date of the claimed invention, it would have been obvious to modify medical device of Truckai to include a display adapted to display ultrasound images generated from the ultrasound sensor as taught by Takikawa in order for the surgeon to monitor the surgical site during the surgery (Takikawa, Paras. [0090]-[0092]). Before the effective filing date of the claimed invention, it would have been obvious to modify medical device of Truckai to include a robotic mechanism coupled to the elongated shaft fully capable to move the resecting tool in at least one direction selected from rotationally, axially, angularly or a combination thereof as taught by Takikawa in order to precisely control the elongated shaft according to a treatment plan (Takikawa, at least Para. [0003] and [0077]).
Regarding claim 19, Truckai discloses that the resecting tool comprises an outer sleeve (115, Fig. 2 and Para. [0035]) coaxial with an inner sleeve (125, Fig. 2 and Para. [0035]) and having respective outer and inner windows (distal-lateral opening/window of 115 and window 118, Fig. 2) and wherein the inner sleeve is rotatable in the outer sleeve to resect tissue (Para. [0035]).
Regarding claim 20, Truckai discloses that the controller is configured to receive signals from the ultrasound sensor and determine when the resecting tool is near an exterior surface of an organ (Paras. [0008], [0013], and [0040])
Regarding claim 21, Truckai discloses that the ultrasound sensor comprises a plurality of piezoelectric transducers (Para. [0028]).
Regarding claim 22, Truckai discloses a fluid source (155, Fig. 1) controlled by the controller for controlling a fluid inflow to a site (Para. [0036]).
Regarding claim 23, Truckai discloses that the controller is configured to control at least one of negative pressure source and the fluid source to control fluid pressure at a treatment site (Paras. [0014], [0036], and [0038]).
Claim(s) 17 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Truckai (US Pub. No.: 2017/0056055) in view of Hashimshony et al. (US Pub. No.: 2008/0039742) and Takikawa et al. (US Pub. No.: 2020/0315724) as applied to claim 16 above, and further in view of Marczyk et al. (US Pub. No.: 2013/0123783)
Regarding claims 17, Truckai in view of Hashimshony and Takikawa discloses substantially all the limitations of the claim as taught above. However, none of Truckai, Hashimshony, and Takikawa disclose that the elongated shaft includes at least one articulating portion.
Marczyk teaches, in the same field of endeavor (medical device for cutting tissue), an elongated shaft includes at least one articulating portion (18, Fig. 1).
Before the effective filing date of the claimed invention, it would have been obvious to modify the elongated shaft of the medical device of Truckai in view of Hashimshony and Takikawa to include at least one articulating portion as taught by Marczyk in order to obtain the advantage of allowing the distal end or end effector of the elongate shaft to move in a wider range of motions inside the body (Marczyk, at least Para. [0091], [0117], and [0122]).
Regarding claim 18, Marczyk further teaches a robotic mechanism configured to articulate the at least one articulating portion (Paras. [0054] and [0130]). Before the effective filing date of the claimed invention, it would have been obvious to modify the medical device of Truckai in view of Hashimshony and Takikawa to include a robotic mechanism configured to articulate the at least one articulating portion as taught by Marczyk in order to obtain the advantage of controlling the articulating portion more precisely.
Claim(s) 24-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Truckai (US Pub. No.: 2017/0056055) in view of Hashimshony et al. (US Pub. No.: 2008/0039742) and Takikawa et al. (US Pub. No.: 2020/0315724) as applied to claim 22, and further in view of Jezierski et al. (US Pub. No.: 2017/0049952).
Regarding claims 24-26, Truckai in view of Hashimshony and Takikawa discloses substantially all the limitations of the claim as taught above. However, none of Truckai, Hashimshony, and Takikawa discloses that [claim 24] where the controller is configured to maintain a selected set pressure in the site; [claim 25] where the controller is configured to adjust a set selected pressure in response to an operating condition; [claim 26] where the operating condition is at least one of (i) a volume of resected tissue, (ii) a number of times the controller de-activated the resecting tool, (iii) a change in sensed pressure in the site, (iv) a rate of change of sensed pressure in the site, and (v) total time of activation of the resecting tool.
Jezierski teaches, in the same field of endeavor (medical device having controller for controlling fluid pressure in the surgical site), a controller (102a, Para. [0075]) configured to maintain a selected set pressure in the site; where the controller is configured to adjust a set selected pressure in response to an operating condition (Paras. [0075] and [0080]-[0082]); where the operating condition is a change in sensed pressure in the site (Paras. [0075] and [0080]-[0082]).
Before the effective filing date of the claimed invention, it would have been obvious to modify the controller of the medical device of Truckai in view of Hashimshony and Takikawa to be configured to maintain a selected set pressure in the site; where the controller is configured to adjust a set selected pressure in response to an operating condition; where the operating condition is a change in sensed pressure in the site as taught by Jezierski in order to obtain the advantage of maintaining desired operational condition to facilitate the surgical operation (Jezierski, Para. [0074], [0091], and [0093]).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-5 and 7-26 have been considered but are moot in view of new ground(s) of rejection.
In response to the argument(s) on pages 8-11 of the remarks, the newly applied teaching reference, Hashimshony et al. (US Pub. No.: 2008/0039742) teaches, in the same field of endeavor (system for resecting tissue), an ultrasound sensor (38, Fig. 2a and 3) carried by a working end of a probe (45, Figs. 2a and 3), where the ultrasound sensor is configured to propagate sound waves (58, Fig. 3) axially and angularly relative to the longitudinal axis of the elongated shaft assembly (Fig. 3).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the ultrasound sensor of system of Truckai to be configured to propagate sound waves axially and angularly relative to the longitudinal axis of the elongated shaft assembly as taught by Hashimshony in order to calculate the distances from the probe to the reflecting boundaries of the target (Hashimshony, Para [0015]) and/or reducing the instrumentation dead time (Hashimshony, Para. [0231]).
Furthermore, Truckai discloses that the controller configured to calculate a limit distance comprising a distance between a tissue resecting component of the resecting tool and a surface of an organ, such that when signals from the ultrasound sensor are sent to the controller, the controller is configured to modulate activation of the tissue resecting component when positioned at less than the limit distance (Paras. [0008], [0013], [0017], and [0049]).
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 JING RUI OU whose telephone number is (571)270-5036. The examiner can normally be reached M-F 9:00am -5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571) 272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JING RUI OU/ Primary Examiner, Art Unit 3771
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