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 .
Response to Arguments
Applicant's arguments filed 01/23/2026 have been fully considered but they are not persuasive.
In the Remarks filed 01/23/2026, Applicant argues that the previously cited prior art of Liu does not anticipate all of the limitations of the amended independent claim. Examiner agrees with this conclusion and offers new grounds of rejection as necessitated by the amended claim under 35 USC 103 detailed below.
Applicant further argues that the claimed invention with respect to the amended claims is not obvious in view of the cited prior art. Namely, Applicant argues that the prior art fails to disclose a guide device within the magnetic resonance-guided laser ablation system and asserts that the cited optical probe tip disclosed in Liu Fig. 7 does not meet the limitations of the guide device because it does not participate in controlling the movement of the fiber tip, and that Pacala does not require a stereotactic driving device or a guide device because it is intended for intravascular use.
With regards, to what is explicitly claimed in the claims, without reading any additional limitations from the specification, the guide device is not structurally limited except for its connection to a far end of the sleeve. Therefore, the probe tip as disclosed in Liu does meet the limitations as claimed because it is connected to the far end of the sleeve and acts as a part of the ablation system by necessarily participating in the manipulation of the system. However, if Applicant is not satisfied with the guide device as taught by Liu, Examiner also presents the guide device taught by Pacala, handle 11 as seen in annotated Fig. 1 provided in the Office Action. The guide device 11 is attached at the far end of the sleeve (labeled in annotated Pacala Fig. 1), and participates in controlling the movement of the fiber tip, as disclosed in Pacala Column 4. Examiner maintains that the cited prior art does teach a guide device as limited by the amended claims.
Applicant further argues that the cited prior art does not meet the connection and positional relationships between the sleeve, connector, and a rotation driving device, as disclosed in the claims. The claims disclose “the near end of the sleeve is connected to the connector, and the far end of the sleeve may extend out from the far end of the guide device; and in a use state, the ablation optical fiber is arranged in the sleeve, the rotation driving device drives the ablation optical fiber to rotate and the axial movement driving device drives the ablation optical fiber along the major axis.”
Examiner disagrees and points to the previous rejection made in view of Pacala which discloses the aforementioned structures of a sleeve, guide device, connector, and rotation/axial movement driving device.
Regarding the connection mode and connector, Applicant argues that the prior art does not disclose a connector as claimed. In the previous rejection, Examiner cited components 5-12 as a connection assembly, and Applicant has identified element 9, a fiber connection nut, as the most fitting element of the assembly. Applicant argues that the connector taught by Liu does not meet the limitations of the claimed invention because the connection disclosed in the present specification is a “plug-in” connection. With regards, to what is explicitly claimed in the claims, without reading any additional limitations from the specification, there are no structural limitations placed on the type of connector/connection in the amended independent claim. Therefore, the connector as taught by Liu or Pacala meets the claimed structural limitations.
With this in consideration, and with regards to the limitations as explicitly stated in the claims, not those only present in the specification, the presented prior art meets the limitations of the amended claims and the rejection under 35 USC 103 is maintined.
Information Disclosure Statement
The Information Disclosure Statement (IDS) filed 06/29/2023 has been considered by the Examiner.
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. Such claim limitation(s) is/are:
“a stereotactic driving system” in claims 1-20; for examination purposes, “a stereotactic driving system” will be interpreted as a structure which accommodates and controls a position and/or rotation angle of the ablation optical fiber as supported in Specification paragraph [0008].
“a guide device” in claims 2-8 and 13-20; for examination purposes “a guide/guiding device” will be interpreted as a structure having a hollow guiding part for an elongated structure and attached to a sleeve as supported in Specification paragraphs [0031-0032].
“rotation driving device” and “axial movement driving device” in claims 2-8 and 13-20; for examination purposes a “rotation driving device” and “axial movement driving device” will be interpreted as a structure that drives rotation and/or axial movement of the optical fiber as supported in Specification paragraphs [0071].
“first driver” and “second driver” in claims 3, 4, and 8; for examination purposes a “first driver” and “second driver” will be interpreted as a motor of hydraulic or pneumatic form as supported by Specification paragraph [0150].
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.
Regarding claim 2 and dependent claims 3 and 4, Examiner is interpreting the limitations of the stereotactic driving system comprising a rotation driving and/or axial movement driving device to be claimed in the alternative in claim 2, thereby the inclusion of a rotation driving system or an axial movement driving system may satisfy the limitation.
In claim 3, the rotational driving device is further limited. Examiner is interpreting the rotational driving device to still be claimed as an option, however, should it be present it must satisfy the further limitations as presented in claim 3.
In claim 4, the rotational driving device is required to have a relationship with the axial movement driving device. Examiner is interpreting the claim as requiring both the rotational driving device as further limited by claim 3, and the axial movement device of claim 2, and for the two driving devices to be in sliding connection with one another.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 3, 5, and 9-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu (CN 108836477 A) in view of Pacala et al (US 6283955 B1).
Regarding claim 1, Liu teaches a magnetic resonance guided laser ablation treatment system (see Abstract of machine translation; magnetic resonance guided laser therapy device and system), comprising:
an ablation optical fiber (see [page 9, paragraphs 2-4 of machine translation]; ablation optical fiber 12);
a laser ablation apparatus, comprising a laser generator and a cooling device (see [page 8, paragraphs 2-4 of machine translation]; laser ablation device 200, cooling device 240);
a stereotactic driving system accommodating and controlling a position and/or a rotation angle of the ablation optical fiber (see [page 7, paragraphs 7-8 of machine translation]; work station 100 controls operation of ablation system to reach predetermined target/ angle); and
a workstation, configured to: control the movement of the stereotactic driving system, and generate and display ablation information of the target region during the workflow of magnetic resonance guided laser ablation treatment system by using magnetic resonance temperature imaging technology (see [page 7, paragraphs 7-8 of machine translation]; work station 100 can use nuclear magnetic monitoring result to control the operation of the probe in order to successfully realize the predetermined ablation target, the main imaging method based on magnetic resonance temperature imaging);
wherein the stereotactic driving system comprises:
a guide device (see Liu Fig. 7; optical probe tip),
a sleeve (see [page 9, paragraph 5 of Liu machine translation]; cooling sleeve),
a connector (see Liu Fig. 5, connector assembly comprising elements 5-12).
Liu is silent regarding the system comprising:
a rotation driving device and an axial movement driving device;
the near end of the sleeve is connected to the connector, and the far end of the sleeve may extend out from the far end of the guide device; and
in a use state, the ablation optical fiber is arranged in the sleeve, the rotation driving device drives the ablation optical fiber to rotate and/or the axial movement driving device drives the ablation optical fiber along the major axis.
Pacala teaches a laser ablation device (10) wherein the system comprises:
a connector (see annotated fig below);
a rotation driving device and an axial movement driving device (see Pacala [col 3, line 51]; optical fiber advancing mechanism 12 is capable of precisely transmitting longitudinal motion and optionally rotational motion to an optical fiber);
the near end of the sleeve is connected to the connector, and the far end of the sleeve may extend out from the far end of the guide device (see annotated Pacala Fig. 1 below); and
in a use state, the ablation optical fiber is arranged in the sleeve, the rotation driving device drives the ablation optical fiber to rotate and/or the axial movement driving device drives the ablation optical fiber along the major axis (see Pacala [col 3, lines 50-58]; the optical fiber advancing mechanism is capable of transmitting longitudinal and/or rotational motion to an optical fiber).
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It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Liu’s magnetic resonance guided laser ablation system with Pacala’s stereotactic driving system. One of ordinary skill in the art would have been motivated to make this modification in order to control the translation and rotation of the ablation probe in order to execute instructions for treating a target tissue of a patient (Pacala [col 4, lines 1-21]).
Regarding claim 3, Liu and Pacala teach the magnetic resonance guided laser ablation treatment system according to claim 2. Liu is silent regarding wherein the rotation driving device comprises a first driver; and
the first driver is connected with the ablation optical fiber, and the first driver drives the ablation optical fiber to rotate about the major axis of the ablation optical fiber.
Pacala teaches wherein the rotation driving device comprises a first driver; and
the first driver is connected with the ablation optical fiber, and the first driver drives the ablation optical fiber to rotate about the major axis of the ablation optical fiber (see Pacala [col 3, lines 50-59]; optical fiber advancing mechanism 12 transmits longitudinal and/or rotational movement to an optical fiber provided by one or more motors).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Liu’s magnetic resonance guided laser ablation system with a first driver to rotate the optical fiber about an axis as taught by Pacala. One of ordinary skill in the art would have been motivated to make this modification in order to control the longitudinal and rotational motion of the ablation probe for precision treatment (see Pacala [col 3, lines 50-55]).
Regarding claim 5, Liu and Pacala teach the magnetic resonance guided laser ablation treatment system according to claim 2. Liu is silent regarding wherein the guide device comprises a hollow guiding part for an elongated structure and a clamping assembly,
the far end of the clamping assembly is connected with the near end of the hollow guiding part for the elongated structure, and
the clamping assembly is used for fixing the relative positions of the sleeve and the hollow guiding part for the elongated structure after the sleeve extends out of the far end of the hollow guiding part for the elongated structure.
Pacala teaches the guide device comprises a hollow guiding part for an elongated structure and a clamping assembly (see Pacala Fig. 3, [col 4, lines 57-67]; guide device 10 having central bore 30 which acts as a hollow guiding part for an elongated structure, and connector 36 acting as a clamping assembly),
the far end of the clamping assembly is connected with the near end of the hollow guiding part for the elongated structure (see Pacala Fig. 3, [col 4, lines 57-67]; far side of connector 36 interfaces with recess 32 at the near end of the guide device 10 for access to bore 30), and
the clamping assembly is used for fixing the relative positions of the sleeve and the hollow guiding part for the elongated structure after the sleeve extends out of the far end of the hollow guiding part for the elongated structure (see Pacala [col 5, lines 1-15]; connector 36 connects optical fiber casing 38, which is considered to be the sleeve, to the hollow guiding part of guide device 10).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Liu’s magnetic resonance guided laser ablation system with the guide device having a hollow guiding part for an elongated structure and a clamping assembly as taught by Pacala. One of ordinary skill in the art would have been motivated to make this modification in order to facilitate connection between the optical fiber and the guide device for user operation, and house the optical fiber within the guide device (Pacala [col 4 lines, 57-67] and [col 5, lines 1-15]).
Regarding claim 9, Liu teaches the magnetic resonance guided laser ablation treatment system according to claim 1, wherein the ablation optical fiber may emit light laterally (see Liu [page 9, paragraphs 7-8 of machine translation]; the optical probe comprising an optical fiber core can be used as a scattering probe or directed laser ablation probe, so it can be appreciated that whether the probe is scattering light in a variety of directions of out of the tip of the probe, the optical fiber may emit light laterally).
Regarding claim 10, Liu teaches the magnetic resonance guided laser ablation treatment system according to claim 1, wherein the workstation may be connected in communication with the laser ablation apparatus and the stereotactic driving system (see Liu [page 7, paragraph 7 of machine translation]; the workstation connected to the laser ablation device and can control the cooling device and adjust the operation plan to successfully realize the predetermined ablation target),
adjust parameters of the laser generator and the cooling device (see Liu [page 7, paragraph 7 of machine translation]; the workstation can control the rotating speed of the peristaltic pump in the cooling device and the power and pulse frequency of the laser device),
control a position and a rotation angle of the ablation optical fiber (see Liu [page 7, paragraphs 7-8 of machine translation]; work station 100 controls operation of ablation system to reach predetermined target/ angle),
perform ablation under magnetic resonance detection (see Liu [page 7 paragraphs 7-8, page 8 paragraph 1 of machine translation]; magnetic resonance temperature imaging techniques), and,
using temperature and ablation information from magnetic resonance images as feedback, perform control over the laser ablation apparatus and the stereotactic driving system (see Liu [page 7, paragraph 7 of machine translation]; work station can adjust the operation plan according to the nuclear magnetic monitoring result and sensor module).
Regarding claim 11, Liu teaches a magnetic resonance guided laser ablation treatment system, comprising:
an optical fiber cooling assembly, accommodating and cooling an ablation optical fiber (see Liu [page 8, paragraphs 2-4 of machine translation]; laser ablation device 200, cooling device 240);
a laser ablation apparatus, comprising a laser generator and a cooling device (see Liu [page 8, paragraphs 2-6 of machine translation]; laser ablation device comprising laser device 250 and cooling device 240);
a stereotactic driving system, accommodating and controlling a position and/or a rotation angle of the ablation optical fiber (see Liu [page 7, paragraphs 7-8 of machine translation]; work station 100 controls operation of ablation system to reach predetermined target/ angle); and
a workstation, configured to: control the movement of the stereotactic driving system, and generate and display ablation information of the target region during the workflow of the magnetic resonance guided laser ablation treatment system by using magnetic resonance temperature imaging technology (see Liu [page 7, paragraphs 7-8 of machine translation]; work station 100 can use nuclear magnetic monitoring result to control the operation of the probe in order to successfully realize the predetermined ablation target, the main imaging method based on magnetic resonance temperature imaging).
Regarding claim 12, Liu teaches the magnetic resonance guided laser ablation treatment system according to claim 11, wherein the optical fiber cooling assembly comprises a cooling liquid conveying pipe, a cooling sleeve (see Liu [page 8, paragraphs 5-6 of machine translation]; the cooling device 240 comprising a cooling substance and cooling pipe), a water circulation adapter assembly and a sealing plug (see Liu [page 9, paragraphs 1-5 of machine translation]; cooling jacket tube 3, cooling sleeve outer tube 4, cooling jacket outer pipe sealing head 1, inlet/outlet assembly 10 and 11).
Allowable Subject Matter
Claims 4, 6-8, and 13-20 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 4 is allowable over the closest prior art of Liu (CN 108836477 A) and Pacala et al (US 6283955 B1).
Liu and Pacala teach the magnetic resonance guided laser ablation treatment system according to claim 3, but are silent regarding wherein the rotation driving device is in sliding connection with the axial movement driving device.
By virtue of its dependence on an allowable parent claim, claim 8 is also allowable.
Claim 6 is allowable over the closest prior art of Liu (CN 108836477 A) and Pacala et al (US 6283955 B1).
Liu and Pacala teach the magnetic resonance guided laser ablation treatment system according to claim 2. Liu further teaches wherein the connector comprises a sealing plug (see Liu Fig. 5; sealing rubber ring 6), an ablation optical fiber connector (see Liu Fig. 5; optical fiber connecting nut 9), a sealing nut/luer taper (see Liu Fig. 5; luer connecter with adapter flange 8 for connecting and sealing), a water inlet adapter (see Liu. Fig. 5; water inlet assembly 5 having inlet 10), and a water outlet adapter (see Liu Fig. 5; water outlet assembly 7 having outlet 11).
They are silent regarding the components being arranged in the sequence of sealing nut, a Luer taper, a water inlet adapter, and a water outlet adapter from near end to far end and the ablation optical fiber connector connected with a transmission part of the rotation driving device, the sealing plug is arranged in the Luer taper, and
an internal protrusion of the sealing nut makes contact with the sealing plug; and
in a use state, the sealing nut is tightened to the Luer taper, the internal protrusion of the sealing nut tightly compresses the sealing plug, and
the ablation optical fiber is arranged within the inside lumen of the ablation optical fiber connector, the sealing nut, the sealing plug and the water inlet adapter to enter the sleeve.
By virtue of its dependence on an allowable parent claim, claim 7 is also allowable.
Regarding claim 13 Liu teaches the magnetic resonance guided laser ablation treatment system according to claim 11. Liu and Pacala are silent regarding the stereotactic driving system comprising:
a guiding device, comprising a cooling sleeve guide part and a guiding device shell;
at least two sensor assemblies, each comprising an angle sensor;
a rotation driving device and/or an axial movement driving device,
the rotation driving device drives the ablation optical fiber to rotate and/or the axial movement driving device drives the ablation optical fiber along the major axis; and
a controller, being connected in communication with the sensor assemblies and the rotation driving device, receiving output angle information from the sensor assemblies, controlling the movement of the rotation driving device and further receiving control information;
wherein in a use state, the far end of the ablation optical fiber is arranged within the inside lumen of the optical fiber cooling assembly, the angle sensors are securely connected to a device or a structure which does not rotate together with the ablation optical fiber
By virtue of their dependence on an allowable parent claim, claims 14-20 are also allowable.
Conclusion
THIS ACTION IS MADE FINAL. 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 ALISHA J SIRCAR whose telephone number is (571)272-0450. The examiner can normally be reached Monday - Thursday 9-6:30, Friday 9-5:30 CT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.J.S./Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792