DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. 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 Amendment
2. Applicant’s Amendment filed December 31, 2025 (hereinafter “12/31/25 Amendment") has been entered, and fully considered. In the 12/31/25 Amendment, claims 1, 3, 4, & 6-9 were amended, and claim 2 was cancelled. No claims were newly added. Therefore, claims 1, & 3-9 are now pending in the application.
3. The 12/31/25 Amendment has overcome the claim objections, and the rejections under §§ 112(b) previously set forth in the Non-Final Office Action mailed 10/28/25 (“10/28/25 Action”).
4. The prior rejection of independent claim 1 under § 103 has been updated to address the amended claim, and maintained.
5. Applicant's arguments are addressed in detail below in the “Response to Arguments” section.
Claim Objections
6. Claim 3 is objected to because of the following informalities:
In claim 3, line 4, the recitation of “a first gripping body coupled to the main body through each of the first flexible tubes” should instead recite --a first gripping body coupled to the main body through a respective one of the first flexible tubes--.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
7. 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.
8. The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
9. Claims 1, 3, 4, 5, & 9 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2012/0179152 to Shin et al. ("Shin") in view of U.S. Patent Application Publication No. 2005/0137659 to Garabedian et al. ("Garabedian").
10. Regarding claim 1, and with reference to the excerpt of FIG. 1 of Shin (provided below), Shin teaches an electrode device comprising:
a plurality of high-frequency electrodes [electrode needles (22) - ¶[0028]; FIGS. 1-2] configured to cauterize a lesion tissue [see ¶[0001] (“a lesion to be cauterized (or ablated)”)];
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EXCERPT OF FIG. 1 OF SHIN
a main body [distribution base (10) - ¶[0028]; FIG. 1] including:
an electrode line [electrode line (11)] configured to supply a high frequency to each of the plurality of high-frequency electrodes [see ¶[0028] (“an electrode line 11 connected to an radio frequency (RF) generator (not shown), and coolant lines 12 are connected to a distribution base 10 that distributes RF waves and coolant. Electrode needles 22 are connected to the distribution base 10 through connection lines 21 to receive RF waves and coolant”); and ¶[0029] (“Although one electrode line 11 is shown in the drawings, as many electrode lines 11 as the number of the electrode needles 22 may be provided”); & ¶[0030] (“three electrode lines 11 may be connected an RF output terminal (RF operation unit) through a 3-in-1 connector to simultaneously supply RF waves to three electrode needles 22”)],
a cooling line [any one of coolant lines (12) - ¶[0028]] configured to circulate and supply cooling water to an inside of each of the plurality of high-frequency electrodes [see ¶[0028] (“…coolant lines 12 are connected to a distribution base 10 that distributes RF waves and coolant. Electrode needles 22 are connected to the distribution base 10 through connection lines 21 to receive RF waves and coolant”); FIG. 1], [and]
…the main body [(10)] being coupled to the plurality of high-frequency electrodes [(22)] via first flexible tubes, respectively [connection lines (21) - see ¶[0028] (“Electrode needles 22 are connected to the distribution base 10 through connection lines 21 to receive RF waves and coolant”)].
A. “MULTI-FUNCTIONAL” ELECTRODE
Shin does not teach that one of the electrodes (22) is a “multi-functional electrode,” and therefore fails to teach the following emphasized claim limitations:
a multi-functional electrode configured to inject a fluid and measure a temperature…;
a temperature sensor disposed inside the multi-functional electrode; and
the main body including:
a fluid line configured to supply the fluid to an inside of the multi-functional electrode, and
a temperature sensor line connected to the temperature sensor, …the main body being coupled to the multi-functional electrode via a second flexible tube.
Garabedian, in a similar field of endeavor, teaches a multi-functional electrode [needle electrode (126) [¶0042]; FIG. 3] configured to inject a fluid [an “infusaid,” such as saline - ¶’s [0008], [0009], [0011], [0040], [0043]] and measure a temperature [e.g., ¶[0044]].
Garabedian teaches a temperature sensor [temperature sensor (127) - ¶[0044]; FIG. 3] disposed inside the multi-functional electrode [¶[0044]].
Garabedian further teaches a perfusion lumen (128) in the probe shaft of needle electrode (126) configured to supply the fluid [the infusaid] to an inside of the multi-functional electrode [needle electrode (126)] [see ¶[0043]; FIG. 3].
Garabedian additionally teaches a temperature sensor line connected to the temperature sensor [signal wires for temperature sensor (127) extend proximally through the probe shaft of needle electrode (126) - see ¶[0044]].
Given that Shin is concerned with device use in various states according to the size and scattering of lesions [e.g., Shin, ¶’s [0007]-[0008]], it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Shin such that one of electrode needles (22) be configured as a “multi-functional” needle electrode configured to inject a fluid and measure a temperature, with a temperature sensor disposed inside the multi-functional electrode, and with a temperature sensor line connected to the temperature sensor, as taught by Garabedian, since such a modification would allow for the provision of a needle electrode which enables the introduction of saline to increase tissue conductivity, thereby enabling creation of a larger (ablation) lesion size [Garabedian, ¶[0005]], and which also provides a more efficient and effective ablation treatment [Garabedian, ¶[0040]].
As modified such that one of electrode needles (22) of Shin be configured as the “multi-functional” needle electrode of Garabedian, one of the fluid lines (12) of Shin connecting to the main body (10) would serve as the fluid line configured to supply the fluid to the perfusion lumen in the probe shaft of the multi-functional needle. Further, the main body (10) in Shin would be coupled to the multi-functional electrode via a second flexible tube [one of the connection lines (21) in Shin that serves to connect its respective needle to the main body (Shin, ¶[0028])].
NOTE: the recitations of “first” and “second” in the new limitations of “first flexible tubes” and “second flexible tube” are being interpreted as labels used to distinguish the flexible tubes that respectively connect the main body to the high-frequency electrodes (i.e., the first flexible tubes) from the flexible tube that connects the main body to the multi-functional electrode (i.e., the second flexible tube).
B. “ANOTHER TISSUE”
Shin was modified above such that one of the electrode needles (22) be configured as a multi-functional electrode. Claim 1 further requires that the multi-functional electrode be:
configured to inject a fluid and measure a temperature of another tissue around the lesion tissue; and
wherein when the multi-functional electrode is measuring the temperature of the another tissue with the temperature sensor, the fluid line is configured to supply no fluid therethrough to the multi-functional electrode.
Because the electrode needles of Shin are each capable of being used and positioned separately, such as when lesions are scattered and located at several positions [Shin, e.g., ¶’s [0008], [0010],[0028]; FIG. 1], the multi-functional electrode of Shin/Garabedian is likewise capable of being introduced into “another tissue” around the tissue such as, e.g., a different lesion tissue, or other tissue [it is noted that claim 1 does not currently specify whether the “another tissue” is a healthy (or non-target) tissue, a different lesion (tumor) tissue, or other tissue].
Further, the multi-functional electrode of Shin/Garabedian is additionally capable of being utilized such that, wherein when the multi-functional electrode is measuring the temperature of the another tissue with the temperature sensor, the fluid line is configured to supply no fluid therethrough to the multi-functional electrode [e.g., ¶[0044] (“The temperature sensor 127 is designed to measure the temperature of the tissue at any given time, thereby providing an indication of whether or not infusaid should be perfused into the tissue”)].
It is noted that “apparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
In the instant case, the device of Shin/Garabedian teaches all of the structural limitations of claim 1 for the reasons set forth above, and, as such, is capable of being used in the manner claimed.
11. Regarding claim 3, the combination of Shin and Garabedian teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Shah further teaches wherein each of the plurality of high-frequency electrodes [(22)] includes:
a first gripping body [dividable base (23) with its widened part (27) for gripping - see ¶’s [0031], [0032], [0038], [0039]; FIG. 1] coupled to the main body [distribution base (10)] through each of the first flexible tubes [through its respective connection line (21)]; and
a first electrode needle [(22)] coupled to a distal portion of the first gripping body [(23)] [see ¶[0031] (“The electrode needle base 20 is divided into two or more dividable bases 23 to which the electrode needles 22 are respectively coupled”); FIG. 1], and
wherein the multi-functional electrode includes:
a second gripping body coupled to the main body through the second flexible tube [again, Shin was modified above (in the rejection of claim 1) such that one of the electrode needles (22) be configured as a multi-functional electrode; as such, the multi-functional electrode would likewise include a second gripping body (dividable base (23) with its widened part (27) for gripping - see ¶’s [0031], [0032], [0038], [0039]; FIG. 1) coupled to the main body (10) through its respective flexible tube (21)]; and
a second electrode needle coupled to a distal portion of the second gripping body [see ¶[0031]].
12. Regarding claim 4, the combination of Shin and Garabedian teaches all of the limitations of claim 3 for the reasons set forth in detail (above) in the Office Action.
Shin was already modified above (in the rejection of claims 1 & 3) such that one of the electrode needles (22) be configured as a multi-functional electrode (as taught by Garabedian), and include the second gripping body/second electrode needle.
Garabedian further teaches wherein at an end portion of the second electrode needle, a plurality of injection holes configured to receive a fluid therethrough are defined [see Garabedian, ¶[0043] (“Alternatively or optionally, side ports (not shown) can be provided in the probe shaft 120 in fluid communication with the perfusion lumen 128. Alternatively, the probe shaft 120 and/or the needle electrode 126 can have a porous structure that allows infusaid to exit out through the pores”); FIG. 7C].
13. Regarding claim 5, the combination of Shin and Garabedian teaches all of the limitations of claim 3 for the reasons set forth in detail (above) in the Office Action.
Shin was already modified above (in the rejection of claims 1 & 3) such that one of the electrode needles (22) be configured as a multi-functional electrode (as taught by Garabedian), and include the second gripping body/second electrode needle.
Garabedian further teaches wherein the temperature sensor [(127)] is disposed at an end portion of the second electrode needle [¶[0044]; FIG. 3 clearly shows temperature sensor (127) at the distal end of the needle].
14. Regarding claim 9, the combination of Shin and Garabedian teaches all of the limitations of claim 3 for the reasons set forth in detail (above) in the Office Action.
Shin further teaches wherein the first gripping body and the second gripping body are combinable with or separable from each other [via the coupling protrusions and coupling grooves on the dividable bases (23) - see ¶’s [0032]-[0037]].
15. Claims 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Shin and Garabedian, and further in view of U.S. Patent Application Publication No. 2014/0303616 to Shin et al. ("Shin ‘616").
16. Regarding claim 6, the combination of Shin and Garabedian teaches all of the limitations of claim 4 for the reasons set forth in detail (above) in the Office Action.
The combination of Shin and Garabedian does not, however, teach:
wherein the multi-functional electrode further includes:
a second movable part movably disposed on the second gripping body; and
a second insulating tube coupled to the second movable part and arranged to surround the second electrode needle.
Shin ‘616, in a similar field of endeavor, teaches a high-frequency heat therapy electrode device [¶[0001]], and teaches that it was known to include a second movable part [sliding part (22) - ¶’s [0047]-[0049]; FIG. 4 (reproduced below)] movably disposed on a gripping body; and
an insulating tube [sheath tube (60)] coupled to the movable part [(22)] and arranged to surround an electrode needle [electrode needle (50)] [see ¶’s [0047]-[0051]; FIG. 4].
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FIG. 4 OF SHIN ‘616
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Shin and Garabedian such that the multi-functional electrode further includes a second movable part movably disposed on the second gripping body and a second insulating tube coupled to the second movable part and arranged to surround the second electrode needle, as taught by Shin ‘616, since such a modification would provide the benefit/advantage of preventing unintended damage/injury to non-target tissue by the tip of the electrode needle during delivery to a treatment site [see Shin ‘616 at ¶[0086]].
17. Regarding claim 7, the combination of Shin, Garabedian, and Shin ‘616 teaches all of the limitations of claim 6 for the reasons set forth in detail (above) in the Office Action.
The combination of Shin & Garabedian was modified above (in the rejection of claim 6) to include the sheath of Shin ‘616, which is designed to cover/protect the electrode needle tip when not in use [when energy is not being delivered].
As such, it logically follows that the combination of Shin, Garabedian, and Shin ‘616 further teaches:
wherein when the fluid [the “infusaid,” such as saline] is being supplied to the multi-functional electrode through the fluid line, the second insulating tube is configured to not cover the plurality of injection holes [i.e., when in use, the distal end of the needle electrode is uncovered (see Garabedian, e.g., FIG. 7C], and
wherein when the multi-functional electrode is measuring a temperature with the temperature sensor, the second insulating tube is configured to cover the plurality of injection holes [Garebdian teaches that temperature may be measured when the device is not in use so as to determine whether the “infusaid” should be delivered - see ¶[0044]].
18. Regarding claim 8, the combination of Shin and Garabedian teaches all of the limitations of claim 3 for the reasons set forth in detail (above) in the Office Action.
The combination of Shin and Garabedian does not, however, teach:
wherein each of the plurality of high-frequency electrodes further includes:
a first movable part movably disposed on the first gripping body, and
a first insulating tube coupled to the first movable part and arranged to surround the first electrode needle.
Shin ‘616, in a similar field of endeavor, teaches a high-frequency heat therapy electrode device [¶[0001]], and teaches that it was known to include a movable part [sliding part (22) - ¶’s [0047]-[0049]; FIG. 4 (reproduced below)] movably disposed on a gripping body; and an insulating tube [sheath tube (60)] coupled to the movable part [(22)] and arranged to surround an electrode needle [electrode needle (50)] [see ¶’s [0047]-[0051]; FIG. 4].
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FIG. 4 OF SHIN ‘616
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Shin and Garabedian such that wherein each of the plurality of high-frequency electrodes further includes a first movable part movably disposed on the first gripping body, and a first insulating tube coupled to the first movable part and arranged to surround the first electrode needle, as taught by Shin ‘616, since such a modification would provide the benefit/advantage of preventing unintended damage/injury to non-target tissue by the tip of the electrode needle during delivery to a treatment site [see Shin ‘616 at ¶[0086]].
Response to Arguments
19. As noted above, the 12/31/25 Amendment has overcome the claim objections, and the rejections under §§ 112(b) previously set forth in the 10/28/25 Action.
20. The prior rejection of independent claim 1 under § 103 has been updated to address the amended claim, and maintained.
21. As it concerns amended independent claim 1, the crux of Applicant’s argument is that the multi-functional electrode of Garabedian is disclosed as being inserted into a treatment region TR, and not “another tissue around the lesion tissue.” More particularly, when discussing ¶[0044] and FIG. 7C of Garabedian, Applicant argues as follows:
Also, according to paragraph [0044], reproduced supra, Garabedian only uses the temperature sensor 127 to measure the temperature of the treatment region TR, such that the temperature sensor 127 is used as a feedback trigger tell when to start or stop the flow of the infusaid into the treatment region TR.
To the contrary, in amended claim 1, the multi-functional electrode is configured to measure a temperature of another tissue around the legion tissue. A non-limiting example of the another tissue may be organs surrounding the legion tissue that should not be damaged. When the multi-functional electrode is measuring the temperature of the another tissue around the lesion tissue, the fluid line is configured to supply no fluid therethrough. A non-limiting example of the effect of such configuration is that the actual temperature of the another tissue around the lesion tissue can be measured more accurately to prevent tissue damage to the another tissue around the legion tissue. See also paragraphs [0048] and [0059], as non-limiting examples.
12/31/25 Amendment, Remarks, pg. 4, emphasis added.
22. Applicant’s arguments have been fully considered, but are not persuasive.
First, Applicant is improperly reading limitations into the claim. Amended claim 1 only recites “another tissue around the lesion tissue.” Nowhere does claim 1 recite that the “another tissue” is a healthy or non-target tissue, nor a “tissue that should not be damaged” as Applicant recites in the argument above. As such, nothing precludes the “another tissue” from being a different lesion (tumor) tissue, or other tissue.
Regardless, and more importantly, the “another tissue” into which the multi-functional electrode is intended to be inserted is not particularly pertinent, as independent claim 1 is an apparatus claim. As noted in the body of the rejection above, “apparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
In the instant case, the device of Shin/Garabedian teaches all of the structural limitations of claim 1 for the reasons set forth above (in the body of the rejection), and, as such, is capable of being used in the manner claimed. Again, because the electrode needles of Shin are each capable of being used and positioned separately, such as when lesions are scattered and located at several positions [Shin, e.g., ¶’s [0008], [0010],[0028]; FIG. 1], the multi-functional electrode of Shin/Garabedian is likewise capable of being introduced into “another tissue” around the tissue such as, e.g., a different lesion tissue, or other tissue.
23. For each of the foregoing reasons, the rejection of independent claim 1 under § 103 based on the combination of Shin and Garabedian has been maintained.
Conclusion
24. 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 extension fee 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 date of this final action.
25. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Bradford C. Blaise whose telephone number is (571)272-5617. The examiner can normally be reached on Monday - Friday 8 AM-5 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Linda Dvorak can be reached on 571-272-4764. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Bradford C. Blaise/Examiner, Art Unit 3794