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 .
Status of Claims
2. This action is responsive to the Preliminary Amendment filed on 12/18/2024.
Claims 1-15 are pending, and have been examined on the merits.
Claim Rejections - 35 USC § 112
3. 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.
4. Claims 11 & 12 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
5. Claim 11 recites the limitation “wherein the interface joint does not include a needle actuator on the housing, the needle actuator being attached to a push rod that extends out of the housing through the outlet for controlling a needle at the distal end of the instrument” in lines 1-4. This recitation renders the claim indefinite, as the claim first recites that the interface joint does not include a needle actuator, but then recites positive limitations concerning the needle actuator (“the needle actuator being attached to a push rod”). As such, it is not clear whether a needle actuator is required or not. For this reason, the structure required by the claim is not clear, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Clarification is required.
For purposes of examination, this limitation is being interpreted as the interface joint not requiring a needle actuator, and therefore not a needle or push rod. This interpretation appears to be consistent with Applicant’s disclosure:
[0042] The tubular member may comprise a hypotube. The hypo tube may be a metal (e.g. stainless steel) tube with a blunt end. The hypo tube may extend into the torquer portion and may therefore bridge a junction between the branched portion and the torquer portion. A metal hypotube may be relatively robust, and may be particularly useful for embodiments utilising high pressure fluid. In particular, in some embodiments, the electrosurgical instrument may omit a needle for puncturing tissue, and may instead utilise a high-pressure fluid which is pressurised for the purpose of puncturing or lifting tissue at a distal end of the instrument. Examples of suitable instruments which may operate in this manner are described in GB application no 2119001.2, which is incorporated herein by reference in its entirety. Therefore, optionally, the interface joint is not configured to integrate a needle movement mechanism into the single cable assembly. For example, optionally, the interface joint does not include a needle actuator (e.g. slidable trigger or pivoting trigger) on the housing, the needle actuator being attached to a push rod that extends out of the housing through the outlet for controlling a needle at the distal end of the instrument. By omitting a needle movement mechanism from the interface joint, the interface joint itself may be made more compact, and may be used in conjunction with instruments that do not utilise a needle and push rod (and can therefore also be more compact).
¶[0042] of Applicant’s published Specification (U.S. 2025/0152229), emphasis added.
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[0081] The single cable assembly 134 comprises a flexible shaft which conveys a coaxial cable 142 and a fluid channel therethrough. The coaxial cable 142 is connected to the electrical inlet 128, and the fluid channel is in fluid communication with the fluid inlet 140 through the conduit 132. The fluid feed cable 141 may be used to convey pressurised fluid to the interface joint. The fluid channel may be configured to convey the pressurised fluid to the instrument tip, for piercing or lifting tissue without requiring the use of a needle. Accordingly, the interface joint 120 does not require a needle actuator and push rod for controlling a needle, and may therefore be relatively compact.
¶[0081] of Applicant’s published Specification (U.S. 2025/0152229), emphasis added.
6. Claim 12 recites the limitation “wherein two or more of the portions of the housing are releasably attachable to each other” in lines 1-2. This recitation renders the claim indefinite, as independent claim 1 (from which claim 12 depends) recites only that “the housing includes a first portion and a second portion.” As such, it is not clear what additional portions of the housing are being referred to by the recitation of “or more of the portions” beyond the two portions recited in claim 1. For this reason, the structure required by the claim is not clear, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Clarification is required.
Claim Rejections - 35 USC § 102
7. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
8. Claims 1, 2, 6, 11, & 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2020/021923, published 01/30/2020, to Ishikawa et al. (“Ishikawa”) [made of record in Applicant’s 12/18/24 IDS]. NOTE: Citations to the text of Ishikawa will be to the paragraph numbers of the machine translation provided by Applicant.
9. Regarding claim 1, Ishikawa discloses an interface joint for interconnecting an electrosurgical generator [high frequency power source (not shown) - ¶[0039]], a fluid supply [syringe (32), or source/supply connected to water supply tube (34) - ¶[0031]; FIGS. 7, 8], and an electrosurgical instrument [high frequency knife (16) provided at tip of wire (14) - ¶[0026]; FIG. 1], the interface joint comprising:
a housing [comprising connector body (18) and operation section body (22) - ¶[0026]; FIGS. 1 & 4] having:
an electrical inlet [electrical connector (40) - ¶[0033]; FIG. 4] for receiving radiofrequency (RF) electromagnetic (EM) energy [¶[0039]] and/or microwave frequency EM energy from the electrosurgical generator [¶[0039]];
a fluid inlet [water injection connector (20) - ¶[0031]; FIGS. 1-4] for receiving fluid from the fluid supply [syringe (32)] [¶[0031]; FIG. 7]; and
an outlet [distal tip of connector body (18) to which sheath (12) is connected - see FIG. 1]; and
a single cable assembly [flexible sheath (12) - ¶[0026]; FIG. 1] for connecting the outlet to an instrument tip of the electrosurgical instrument [high frequency knife (16) provided at tip of wire (14) - ¶[0026]; FIG. 1], the single cable assembly [(12)] comprising a flexible shaft [flexible sheath (12) - ¶[0026]] having:
a coaxial cable [wire (14) - ¶[0028]; FIG. 1] that is connected to the electrical inlet [(40)] [¶[0039]]; and
a fluid channel [extending from internal space (24) of water injection connector (20) to distal end (26) of sheath (12) - ¶[0032]] that is in fluid communication with the fluid inlet [(20)];
wherein the housing [(18, 22)] includes a first portion [operation section body (22) - FIG. 4] and a second portion [connector body (18) - FIG. 4], the second portion [(18)] being attached to the single cable assembly [sheath (12)] [¶[0029]] such that rotation of the second portion [(18)] effects rotation of the single cable assembly [(12)] [NOTE: the proximal end of sheath (12) is connected to connector main body (18) which rotates around rotation axis (28) (see ¶[0029); as such, sheath (12) rotates with connector main body (18)]; and
the first portion [(22)] being rotatable relative to the second portion [(18)] [¶[0029]];
wherein the first portion [(22)] includes a first inlet [electrical connector (40)] and the second portion [(18)] includes a second inlet [water injection connector (20)], wherein the first inlet [(40)] is one of the fluid inlet or electrical inlet [the first inlet is electrical connector (40) - FIGS. 2, 4], and the second inlet [water injection connector (20)] is the other of the fluid inlet or electrical inlet [the second inlet is water injection connector (20) - FIGS. 1, 2, 4, 7].
10. Regarding claim 2, Ishikawa discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Ishikawa further discloses a fluid feed cable [water supply tube (34) - ¶[0031]; FIG. 8] connected to the fluid inlet [(20)] for conveying fluid from the fluid supply to the interface joint.
11. Regarding claim 6, Ishikawa discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Ishikawa further discloses wherein the first inlet [(40)] is the electrical inlet [the first inlet is electrical connector (40) - FIGS. 2, 4], and the second inlet [(20)] is the fluid inlet [the second inlet is water injection connector (20) - FIGS. 1, 2, 4, 7].
12. Regarding claim 11, Ishikawa discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
As best understood [see rejection under § 112(b) above], Ishikawa further discloses wherein the interface joint does not include a needle actuator on the housing, the needle actuator being attached to a push rod that extends out of the housing through the outlet for controlling a needle at the distal end of the instrument [Ishikawa does not disclose a needle or needle actuator].
13. Regarding claim 12, Ishikawa discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
As best understood [see rejection under § 112(b) above], Ishikawa further discloses wherein two or more of the portions of the housing are releasably attachable to each other [the first portion (operation section body (22)) and the second portion (connector body (18)) are releasably attached to one another - compare FIG.1 (connected/attached) and FIG. 4 (disconnected/detached)].
Claim Rejections - 35 USC § 103
14. 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.
15. 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.
16. Claims 13 & 14 are rejected under 35 U.S.C. 103 as being unpatentable over Ishikawa in view of U.S. Patent Application Publication No. 2019/0282402 to Clauson et al. ("Clauson").
17. Regarding claim 13, Ishikawa discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Ishikawa further discloses:
a fluid feed cable [water supply tube (34) - ¶[0031]; FIG. 8] for conveying fluid to the fluid inlet [water injection connector (20)] from the fluid supply; [and]
an EM feed cable [cable - ¶[0039]] for conveying the EM energy from the electrosurgical generator [high frequency power source (not shown) - ¶[0039]] to the electrical inlet [electrical connector (40) - ¶[0033]; FIG. 4].
Ishikawa does not teach:
a cable management structure for securing a section of a feed cable to the interface joint, the feed cable being either [the fluid feed cable or the EM feed cable].
However, the use of cable management structures for securing cables/tubes/lines etc. to a handpiece of a surgical instrument were well known in the art, before the effective filing date of the claimed invention.
As one example, Clauson, in a similar field of endeavor, teaches the use of clips (1747) to attach a tube or fluid line (1749) to a controller (1742) [see ¶[0126] (“the controller 1742 can be attached to a tube or fluid line 1749 extending proximally from the housing 1746 using the one or more clips 1747”); FIG. 31 (reproduced below)].
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FIG. 31 of CLAUSON
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Ishikwawa to include a cable management structure [e.g., such as the clip(s) of Clauson] for securing a section of a feed cable to the interface joint, since such a modification would provide the benefit/advantage of maintaining the feed cable in a secure position to prevent interference with a surgeon’s hand (and/or other parts of the device) during a procedure.
18. Regarding claim 14, the combination of Ishikawa and Clauson teaches all of the limitations of claim 13 for the reasons set forth in detail (above) in the Office Action.
Claim 14 further requires the limitation “wherein the feed cable is connected to the second inlet.”
In Ishikawa, the fluid feed cable [water supply tube (34) - ¶[0031]; FIG. 8] for conveying fluid to the fluid inlet [water injection connector (20)] from the fluid supply is connected to the second inlet [as established in the rejection of claim 1 above, the second inlet is water injection connector (20) - FIGS. 1, 2, 4, 7].
Clauson teaches that the clips (1747) are used to secure fluid line (1749) [¶[0126]; FIG. 31].
19. Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Ishikawa in view of U.S. Patent Application Publication No. 2020/0246068 to Hancock et al. ("Hancock") [made of record in Applicant’s 12/18/24 IDS].
20. Regarding claim 15, Ishikawa discloses a kit of parts including:
the interface joint of claim 1 [see the rejection of claim 1 above which is incorporated herein].
Ishikawa does not, however, disclose:
a torque transfer unit attachable to the single cable assembly such that rotation of the torque transfer unit effects rotation of the single cable assembly.
Hancock, in a similar field of endeavor, teaches an interface joint (106), the function of which is to combine inputs from a generator (102), fluid delivery device (108) and needle movement mechanism into a single flexible shaft (112), which extends from the distal end of the interface joint (106) [¶[0038; FIG. 1].
Hancock further teaches a torque transfer unit [(116)] attachable to the single cable assembly [(112)] such that rotation of the torque transfer unit [(116)] effects rotation of the single cable assembly [(112)] [see ¶[0040] (“A torque transfer unit 116 may be mounted on a proximal length of the shaft 112 between the interface joint 106 and endoscope 114. The torque transfer unit 116 engages the shaft to permit it to be rotated within the instrument channel of the endoscope 114”)].
Given that the sheath (12) of Ishikawa is likewise configured to be inserted into a treatment insertion channel of an endoscope during ESD treatment [see ¶[0027]], it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Ishikawa to include a torque transfer unit attachable to the single cable assembly such that rotation of the torque transfer unit effects rotation of the single cable assembly, since such a modification would provide the benefit/advantage of allowing the sheath (12) of Ishikawa to be rotated within the instrument channel of the endoscope, as explicitly taught by Hancock. Still further, all the claimed elements were known in the prior art (as demonstrated by Ishikawa and Hancock), and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
Allowable Subject Matter
21. Claims 3-5 & 7-10 are 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.
22. Dependent Claims 3-5
23. In addition to the limitations of independent claim 1, dependent claim 3 further requires:
wherein the second portion comprises a conduit defining a branched passageway, the branched passageway having a first length in line with the first inlet and the outlet, and a second length having the second inlet (emphasis added).
In Ishikawa, the second portion [connector body (18) - FIG. 4] includes a branched passageway that is formed by water injection path (21) and internal space (24) [¶’s [0028], [0031], FIG. 4]. The base end of wire (14) is inserted into the internal space (24) [see ¶[0028]], and the water injection path (21) also communicates with internal space (24) [see ¶[0031]].
However, the branched passageway does not have a first length in line with the first inlet [electrical connector (40)] and the outlet [distal tip of connector body (18) to which sheath (12) is connected]. NOTE: the limitation “in line with” is being interpreted as sharing a straight line or single, central axis (i.e., an exact alignment, with no offset). Rather, electrical connector (40) is disposed perpendicular to the outlet [see FIG. 4]. Further, absent hindsight, there would be no apparent reason to “re-position” the electrical connector (40) to be “in line with” the outlet, since to do so would apparently require the connector (40) to somehow be connected to (and extend from) finger ring (46), which would seemingly interfere with use of the finger ring. For this reason, dependent claim 7 is patentable over the references of record.
24. Dependent claims 4 & 5 depend from allowable dependent claim 3, and are therefore allowable at least by virtue of their dependency from claim 3.
25. Dependent Claims 7-10
26. In addition to the limitations of independent claim 1, dependent claim 7 further requires:
wherein the second portion includes a branched portion and a torquer portion, the branched portion being rotatable relative to the torquer portion, wherein the branched portion includes the second inlet and the torquer portion includes the outlet.
Neither Ishikawa nor the other references of record, either alone or in combination, appear to fairly teach or suggest the foregoing claimed configuration of the “second portion” in combination with the limitations of independent claim 1. For this reason, dependent claim 7 is patentable over the references of record.
27. Dependent claims 8-10 depend from allowable dependent claim 7, and are therefore allowable at least by virtue of their dependency from claim 7.
Conclusion
28. 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, Joanne M. Rodden can be reached on 303-297-4276. 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/Primary Examiner, Art Unit 3794
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