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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 14 January 2026 has been entered.
Claim Rejections - 35 USC § 112
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.
Claims 1, 3, 6, 7, 11-13 are 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 1 refers to both “an outer cannula wall of the biopsy cannula” and “an outer wall of the biopsy cannula”; if these are the same element it should be referred to consistently throughout the claims. Clarification is required.
Claim 1 defines a temperature measurement probe on the outer wall of the biopsy cannula of the system; claim 7 recites that “the system includes a temperature measurement probe”, where it is unclear if this is the same probe or an additional probe as this probe has already been defined as included as part of the system as per claim 1. The same issue is found in claims 12 and 13. Clarification is required.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1, 6, 12, 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cosman (WO 2021/108730, which corresponds to US 2022/0401085; citations below are to the US document) in view of Young (US 2007/0088347).
Regarding claims 1 and 5, Cosman discloses an active biopsy apparatus with a needle passage ablation function, comprising:
a radio frequency generator (paragraphs [0055], [0059], [0078]), a biopsy cannula (element 150), a biopsy tool (element 370), an ablation electrode intermediate pole (element 320), and a negative radio frequency plate (paragraph [0004]; element 140);
wherein the biopsy cannula comprises a connection to the radio frequency generator by a first connecting line (paragraph [0059], the connection for element 154B); and
an outer cannula wall of the biopsy cannula is a radio frequency ablation electrode (element 154B), and
the biopsy tool is configured to be movably arranged inside the biopsy cannula (paragraph [0080]);
the ablation electrode intermediate pole is an electrode needle (element 320);
the electrode needle is configured to be movably arranged inside the biopsy cannula (figure 3);
an insulation layer is configured to be arranged between an inner wall of the electrode needle and an outer wall of the biopsy cannula (paragraph [0085]);
a tail portion of the electrode needle is connected to a first radio frequency port of the radio frequency generator by a second line (element 321);
the radio frequency generator comprises the first and a second radio frequency port respectively connected to the biopsy cannula and the negative radio frequency plate by the connecting lines (paragraph [0089]);
the biopsy cannula is configured to be used in a biopsy only as a passive device (paragraph [0054]);
the biopsy cannula is configured to cooperate with the biopsy tool to carry out a biopsy operation (paragraph [0054]); and
the biopsy tool in the biopsy cannula is configured to be taken out once the biopsy operation is completed, the electrode needle is configured to be inserted into the biopsy cannula, and the biopsy cannula is configured to carry out ablation and hemostasis for a needle passage (paragraph [0055], [0080], [0089]);
wherein the apparatus is free of a fluid cooling system that cools the ablation electrode (paragraph [0192], cooling system components can be omitted), and
wherein a temperature measurement probe is located on the outer wall of the biopsy cannula at a “front end” of the outer wall of the biopsy cannula (paragraph [0189], “the ablation electrodes (120, 220, 320, 520, 620, 720, 820, 920, 1120, 1220, 1320, 1420) and cannula (150, 550, 650, 1050, 1650, 1750, 1850, 1950) can each include more than one temperature sensor at multiple location along the shaft… information about the geometry of heating around the electrode”; in the absence of a specific physical location any of these locations could be considered a “front end” of the cannula; paragraph [0097], “temperature directly measures tissue heating”; paragraph [0165], “The display of temperature of a biopsy tract coagulation electrode per se is an aspect of the present invention and is useful because it directly measures tissue heating”; as the outer wall of the cannula is the cannula electrode and the temperature sensor of the cannula measures temperature of the electrode, thus the outer wall, and the surrounding tissue, external of the cannula and thus inherently not able to be sensed by a temperatures sensor internal in the cannula, the temperature measurement probe is thus located on the outer wall).
Cosman does not discuss details of the radio frequency generator, particularly having a maximum output of 100 Watts.
Young teaches a radio frequency generator for ablation which has a maximum radio frequency output power of 100W (paragraph [0038]; ” In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)”, see MPEP 2144.05). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the system of Cosman, as modified, with the radio frequency generator having a maximum radio frequency output power of 100W, as taught by Young, in order to avoid causing injury to the patient.
Regarding claim 6, Cosman, as modified, does not disclose that the radio frequency generator is set with an ablation time of 3-8 seconds; however, "where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (see MPEP 2144.05). Cosman teaches ablation taking place over limited periods (see figure 1B, the illustrated pulsed impedances on element 100) and that an ablation time may be set (paragraph [0074]), but does not specify use of a particular duration, but as the amount of time required will inherently vary based at least on conditions of the tissue type and target size, it would have been obvious to one of ordinary skill in the art to have made the system of Cosman, as modified, and determined an optimal range of ablation time, such as 3-8 seconds, as part of increasing efficiency of use of the system.
Regarding claims 12 and 13, Cosman, as modified, further discloses the system comprising a temperature measurement probe (paragraph [0059], “a temperature sensor included in the electrode tip”) and that the active biopsy system is configured to perform the biopsy operation and then the needle passage ablation function (paragraph [0059]), wherein the biopsy operation and the needle passage ablation function comprise the following processes:
step 1, using the biopsy cannula in combination with the biopsy tool, and placing the biopsy cannula and the biopsy tool on a target lesion for biopsy sampling (paragraphs [0054], [0088]);
step 2, withdrawing the biopsy tool from the biopsy cannula to obtain a biopsy sample (paragraphs [0055], [0088]);
step 3, inserting the electrode needle into the biopsy cannula (paragraph [0055]); and
step 4, operating the radio frequency generator to start an ablation mode, operating the temperature measurement probe, and feeding back an ablation temperature to the active biopsy system in real time (paragraphs [0056], [0057], [0089].
Claim(s) 3, 7, 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cosman, as modified by Young above, and further in view of Sharon (US 2011/0060188).
Regarding claims 3 and 11, Cosman does not disclose the biopsy tool being a disposable biopsy brush or a disposable biopsy forceps. Sharon teaches a biopsy tool in the form of disposable biopsy forceps (paragraph [0048]). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the system of Cosman, as modified, with disposable biopsy forceps, as taught by Sharon, in order to alleviate the need for complex sterilization and cleaning procedures (Sharon paragraph [0005]).
Regarding claim 7, Cosman further discloses a temperature measurement probe in the system (paragraph [0059], “a temperature sensor included in the electrode tip”), and that the active biopsy system is configured to perform the biopsy operation and then the needle passage ablation function (paragraph [0059]), wherein the biopsy operation and the needle passage ablation function comprise the following processes:
step 1, using the biopsy cannula in combination with the biopsy tool, and placing the biopsy cannula and the biopsy tool on a target lesion for biopsy sampling (paragraphs [0054], [0088]);
step 2, withdrawing the biopsy tool from the biopsy cannula to obtain a biopsy sample (paragraphs [0055], [0088]);
step 3, inserting the electrode needle into the biopsy cannula (paragraph [0055]); and
step 4, operating the radio frequency generator to start an ablation mode, operating the temperature measurement probe, and feeding back an ablation temperature to the active biopsy system in real time (paragraphs [0056], [0057], [0089].
Response to Arguments
Applicant's arguments filed 5 December 2025 have been fully considered but they are not persuasive.
Applicant argues that Cosman does not disclose a temperature measurement probe on the outer cannula wall/outer wall of the cannula, asserting that Cosman does not disclose a location of the disclosed cannula temperatures sensor. As noted above, Cosman extensively discusses the purpose of including temperature measurement probes as part of the disclosed system, where the temperature measurement probes are used for measuring electrode temperature and adjacent tissue temperature – both of which would require the temperature measurement probe of the cannula to be on its outer wall, in order to be adjacent to the electrode of the outer wall itself, and, more particularly, to sense the temperature of tissue adjacent the cannula, since only the outer wall of the cannula can be in contact with that tissue.
Applicant then presents multiple arguments as to whether “modifying” Cosman by “relocating” the sensor would be successful, would require impermissible hindsight, or would be related to some previously unidentified problem; it is unclear why these have been included, as there is no rejection whatsoever presented in the previous Office Action or above that relies upon modifying Cosman by relocating or changing the location of its temperature sensor, such that these remarks are moot.
The Examiner notes that Applicant addresses the dependent claims only to reiterate the supposed deficiencies of Cosman, and does not present remarks to any other applied reference.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: US 6162216 to Guziak, which also discloses a biopsy and ablation system with a temperature measurement probe on an outer wall at a “front end” of its cannula.
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/KAREN E TOTH/ Examiner, Art Unit 3791
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