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 Amendment
This action is in response to the remarks filed on 6/10/2026.
The amendments filed on 6/10/2026 have been entered. Accordingly claims 1-18 remain pending. Claim 6 is cancelled.
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.
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.
Claims 1-5, 7, 9, 11, and 13-18 are rejected under 35 U.S.C. 103 as being unpatentable over Gogolin (US20220071684A1) in view of Germain et al (US20210145502A1).
Regarding claim 1, Gogolin teaches a plasma probe for treatment of biological tissue (“systems and methods of the present disclosure may be used for a minimally invasive application of helium-based cold plasma energy to subcutaneous tissue for the purpose of tightening lax tissue” abst), comprising:
a flexible hose extending from a proximal end along a longitudinal center axis (L) to a distal end (“shaft 604 is configured to enable a degree of flexibility (e.g., bending of shaft 604) to facilitate the insertion of tip 606 and shaft 604 through subdermal tissue” [0159]), the flexible hose further comprising:
a lumen connectable to a gas source (“Connector 623 is provided for coupling the apparatus 600 to an electrosurgical generator. The connector 623 receives electrosurgical energy and inert gas from the electrosurgical generator and/or a gas source” [0158]),
an electrical conductor extending from the proximal end to the distal end, wherein the electrical conductor is configured to be connected to an electrical generator, an electrode connected to the electrical conductor (“Apparatus 600 includes an electrically conducting member or electrode 618 (shown in FIG. 9B), e.g., a conductive rod, wire, or other suitable electrode, disposed through shaft 604. In one embodiment, electrode 618” [0159]),
and a head piece attached to the distal end of the flexible hose, the head piece having an end section tapering in a distal direction (“Distal end 631 of tip 606 includes an exterior surface or wall 632 shaped as an elliptic paraboloid or an elliptical cone with a blunted or rounded tip 633 converging toward distal end 631.” [0163]),
wherein at least one plasma exit window is configured in the head piece, the plasma exit window is at least partly arranged in the tapering end section (“Tip 606 includes a distal end 631 and a proximal end 635. The proximal end 635 of tip 606 includes male interlocking members or tabs 646A, 646B and female interlocking slots, which are each disposed between male interlocking members 642A, 642B. Tip 606 includes a port 630 disposed through a side wall of tip 606 and oriented in a radial direction traverse to axis 670” [0161]).
Gogolin does not point out the specifics of head piece having an end section tapering in a distal direction, wherein the tapering end section is longitudinally rounded; and the plasma exit window is at least partly arranged in the tapering end section, and the head piece is closed at its distal end having no plasma exit window providing an axial exit direction.
However, in the same field of endeavor, Germain teaches tissues are treated by generating a plasma in an interior space of a probe and exposing the tissue to the plasma. The plasma is released through a gap in a working end of the probe (abst). In FIG. 16, it can be seen that a round or oval probe shaft 610. The interface 615 between the ceramic bodies 612A and 612B (see FIG. 18A), terminating in gap G in the surface 618, can be extremely tight and in one embodiment the interface is sufficiently fluid-tight to prevent liquid flow therethrough but still permit electrons and plasma to propagate through the interface 615. 620A and 620B are disposed entirely within the interior of ceramic bodies 612A and 612B with no exposure in the working surface 618 or shaft 610 [0073].
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It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with head piece having an end section tapering in a distal direction, wherein the tapering end section is longitudinally rounded; and the plasma exit window is at least partly arranged in the tapering end section, and the head piece is closed at its distal end having no plasma exit window providing an axial exit direction as taught by Germain because devices cause unacceptable thermal damage to cartilage tissue and therefore what is needed are systems and methods that can controllably apply energy to fibrillated or damaged cartilage to smooth the cartilage without any thermal damage to the cartilage surface layers ([0003]-[0004] of Germain).
Regarding claim 2, Gogolin teaches wherein the head piece is made of a heat-resistant electrically insulating material (“tip 806 is made of ceramic material” [0184]).
Regarding claim 3, Gogolin teaches wherein the plasma exit window is orientated transverse to the longitudinal center axis (L) (“Tip 606 includes a port 630 disposed through a side wall of tip 606 and oriented in a radial direction traverse to axis 670” [0161]).
Regarding claim 4, Gogolin teaches wherein the head piece further comprises multiple plasma exit windows distanced from one another in circumferential direction at the same axial position, which are at least partly arranged in the tapering end section (“Ports 6030A, 6030B are each configured with the features of port 630 described above. Ports 6030A, 6030B are diametrically opposed with respect to axis 670, such that ports 6030A, 6030B are oriented in opposite directions” [0167]).
Regarding claim 5, Gogolin teaches wherein the tapering end section is rounded/longitudinally rounded (“Distal end 631 of tip 606 includes an exterior surface or wall 632 shaped as an elliptic paraboloid or an elliptical cone with a blunted or rounded tip 633 converging toward distal end 631.” [0163]).
Regarding claim 7, Gogolin teaches wherein the head piece has a circular cross-section having a radius (R) at its hose side end, which is smaller than a length (D) measured from the hose side end to a tip of the head piece (see fig. 9B).
Regarding claim 9, Gogolin teaches wherein the electrode is fixated in the head piece (“A distal end 620 of electrode 618 is securely received by the slot 624 of interior 622 such that a distal portion electrode 618 is disposed adjacent to port 630” [0163]).
Regarding claim 11, Gogolin teaches wherein the hose comprises one single gas conveying lumen (“Shaft 604 is made of a non-conducting material and is configured to provide inert gas to tip 606” [0159]).
Regarding claim 13, Gogolin teaches wherein wherein the head piece comprises only one single plasma exit window (“Port 630 is disposed through a side wall of tip 606 such that port 630 is oriented in a radial direction with respect to axis 670” [0163]).
Regarding claim 14, Gogolin teaches wherein the tapering section of the head piece is figured rotationally symmetrically relative to the longitudinal center axis (L) (see figs. 9B-F).
Regarding claim 15, Gogolin teaches wherein the tapering section of the head piece is asymmetrically con- figured relative to the longitudinal center axis (L) (see figs. 9B-D).
Regarding claim 16, Gogolin teaches all the claimed limitations except for the head piece comprises exclusively lateral at least one plasma exit.
However, in the same field of endeavor, Germain teaches tissues are treated by generating a plasma in an interior space of a probe and exposing the tissue to the plasma. The plasma is released through a gap in a working end of the probe (abst). In FIG. 16, it can be seen that a round or oval probe shaft 610. The interface 615 (lateral as seen in re-produced fig. below) between the ceramic bodies 612A and 612B (see FIG. 18A), terminating in gap G in the surface 618, can be extremely tight and in one embodiment the interface is sufficiently fluid-tight to prevent liquid flow therethrough but still permit electrons and plasma to propagate through the interface 615. 620A and 620B are disposed entirely within the interior of ceramic bodies 612A and 612B with no exposure in the working surface 618 or shaft 610 [0073].
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It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with the head piece comprises exclusively lateral at least one plasma exit as taught by Germain because devices cause unacceptable thermal damage to cartilage tissue and therefore what is needed are systems and methods that can controllably apply energy to fibrillated or damaged cartilage to smooth the cartilage without any thermal damage to the cartilage surface layers ([0003]-[0004] of Germain).
Regarding claim 17, Gogolin teaches all the claimed limitations except for the plasma exit window is arranged transverse and obliquely to the longitudinal center axis.
However, in the same field of endeavor, Germain teaches tissues are treated by generating a plasma in an interior space of a probe and exposing the tissue to the plasma. The plasma is released through a gap in a working end of the probe (abst). In FIG. 16, it can be seen that a round or oval probe shaft 610. The interface 615 (transverse and obliquely to the longitudinal center axis as seen in re-produced fig. below) between the ceramic bodies 612A and 612B (see FIG. 18A), terminating in gap G in the surface 618, can be extremely tight and in one embodiment the interface is sufficiently fluid-tight to prevent liquid flow therethrough but still permit electrons and plasma to propagate through the interface 615. 620A and 620B are disposed entirely within the interior of ceramic bodies 612A and 612B with no exposure in the working surface 618 or shaft 610 [0073].
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It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with plasma exit window is arranged transverse and obliquely to the longitudinal center axis as taught by Germain because devices cause unacceptable thermal damage to cartilage tissue and therefore what is needed are systems and methods that can controllably apply energy to fibrillated or damaged cartilage to smooth the cartilage without any thermal damage to the cartilage surface layers ([0003]-[0004] of Germain).
Regarding claim 18, Gogolin teaches wherein the head piece has no plasma exit window providing an axial exit direction in line with the longitudinal center axis (L) (see fig. 9B).
Claims 8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Gogolin in view of Germain and further in view of Williams (US 20130090644).
Regarding claim 8, above noted combination teaches all the claimed limitations except for the electrode is fixated in the hose.
However, in the same field of endeavor, Williams teaches the needle electrode 4 is formed as an axial extension of a conductive mounting plate 4M supported by the wall of the tube 3 so as to lie on the tube axis [0028].
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with electrode is fixated in the hose as taught by Williams because it helps to provide an instrument which is more versatile than any of the instruments ([0002] of Williams).
Regarding claim 10, above noted combination teaches all the claimed limitations except for the electrode comprises a distal end that does not contact the head piece.
However, in the same field of endeavor, teaches tube is conveniently flexible, such that it can be used in endoscopic surgical procedures, in which the tube is required to reach the intended surgical site via a lumen within the body of a patient [0008]. The instrument is shown schematically in position adjacent tissue 7, to which is connected a patient return pad 8, connecting the tissue to the generator 5. The interior of the tube 3 constitutes a gas conduit and, at a distal end portion, the tube 3 is provided with apertures, shown generally at 9, through which the argon gas supplied via the conduit can exit the tube. In use, the gas flows down the tube over the electrode 4, which causes the gas to ionize and form a plasma [0024]. Also see figs. 1-4 and the associated pars.
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with electrode comprises a distal end that does not contact the head piece as taught by Williams because it helps to provide an instrument which is more versatile than any of the instruments ([0002] of Williams).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Gogolin in view of Germain and further in view of Platt (US 6039736 A).
Regarding claim 12, above noted combination teaches all the claimed limitation except for the hose comprises multiple gas conveying lumens.
However, in the same field of endeavor, Platt teaches two electrodes and two angularly disposed surfaces located within the tube which operate in pairs to reflect the ionizable gas at a different angle at the tissue as shown in fig. 5 and the associated sections.
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with as taught by Platt because there is a need exists for the development of a new and effective instrument for treating certain more tubular tissue (background of Platt).
Response to Arguments
Applicant’s arguments have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 SERKAN AKAR whose telephone number is (571)270-5338. The examiner can normally be reached 9am-5pm M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Koharski can be reached at 571-272 7230. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SERKAN AKAR/ Primary Examiner, Art Unit 3797
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