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 .
Information Disclosure Statement
The information disclosure statement(s) filed on the record are in compliance with the content requirements of 37 CFR 1.97 and 37 CFR 1.98 and have been considered.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the "discharge opening" (claim 1) and "the elongate insertion shaft comprises an endoscope" (claim 7) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Election/Restriction
Claims 14-26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/20/2026.
Claim Objections
Claims 14-26 objected to because of incorrect status identifiers. These claims should be identified as "Withdrawn".
Appropriate correction is required.
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, 8 and all claims depending therefrom 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 recites "an elongate insertion shaft comprising:…a first electrode connected to the elongate insertion shaft…; and a second electrode connected to the elongate insertion shaft…". It is unclear how the elongate insertion shaft could "comprise" first and second electrodes that also are "connected" to the same shaft.
For the purpose of examination, the claim will be interpreted to mean a first electrode connected to a portion of the elongate insertion shaft…; and a second electrode connected to a portion of the elongate insertion shaft
Claim 6 recites "the second electrode extends from the elongate insertion shaft", which is inconsistent with claim 1 (upon which claim 6), in which the insertion shaft comprises the second electrode. It is not clear how the second electrode could be part of the elongate insertion shaft and extend from the elongate insertion shaft.
For the purpose of examination, the claim will be interpreted to mean the second electrode extends from a portion of the elongate insertion shaft.
Claim 8 recites that "the second electrode comprises a trocar device, wherein the trocar device comprises a tubular body into which the elongate insertion shaft is inserted," which is inconsistent with claim 1 (upon which claim 6), in which the insertion shaft comprises the second electrode.
For the purpose of examination, the claim will be interpreted to mean that the second electrode comprises a trocar device, wherein the trocar device comprises a tubular body into which a portion of the elongate insertion shaft is inserted.
Claim Rejections - 35 USC § 102
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 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.
Claims 1-4, 7, 9, 10 and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hradetzky et al (U.S. 9,731,306 B2, hereinafter "Hradetzky").
Regarding claim 1, Hradetzky discloses a surgical material delivery system comprising:
an elongate insertion shaft (see Fig. 3 showing shaft 1; and see col. 12, lines 62-64 disclosing the device 1 along with an endoscope, such that the shaft includes both the endoscope and the device 1) comprising:
a passageway (spray chamber 31; see Fig. 3) extending at least partially through the elongate insertion shaft; and a discharge opening (at the end of housing 30; see Fig. 3) fluidly connected to the passageway (see also col.11, lines 65-66);
a first electrode 100 (see Fig. 3) connected to a portion of the elongate insertion shaft and configured to impart an electrical charge to surgical material flowing through the passageway (see col. 13, lines 19-22; and see Fig. 3 showing negative charge applied to droplets "D" of material); and
a second electrode 200 (see Fig. 3) connected to a portion of the elongate insertion shaft and configured to impart an electrical charge to tissue in contact with the second electrode (see col. 10, lines 45-48 and col. 13, lines 19-22; and see Fig. 3 showing positive charge applied to contact area 200a of tissue "T" that contacts the second electrode 200).
Regarding claim 2, Hradetzky discloses the surgical material delivery system of claim 1, wherein the first electrode comprises:
a first conductor (see col. 13, line 21 referring to electrode 100 as "electrically conductive) extending along the elongate insertion shaft for coupling to an electrical generator 300 (see Fig. 2); and a ring attached to the elongate insertion shaft (see Fig. 1 showing the ring as the portion through which the reservoir 10 is inserted).
Regarding claim 3, Hradetzky discloses the surgical material delivery system of claim 1, wherein the first electrode comprises:
a first conductor (see col. 13, line 21 referring to electrode 100 as "electrically conductive) extending along the elongate insertion shaft for coupling to an electrical generator 300 (see Fig. 2);
and a metallic spray tip 11 (see Fig. 2) connected to the discharge opening; wherein the metallic spray tip is configured to produce a variable diameter spray pattern of the surgical material (see col. 3, line 60 to col. 4, line 7 describing both the metallic spray tip and the variable diameter spray ability).
Regarding claim 4, Hradetzky discloses the surgical material delivery system of claim 1, wherein the second electrode extends from the elongate insertion shaft distally of the discharge opening and is retractable proximally of the discharge opening (see col.3, line 60 to col. 4, line 9).
Regarding claim 7, Hradetzky discloses the surgical material delivery system of claim 4, wherein the elongate insertion shaft comprises an endoscope (see col. 12, lines 62-64; an endoscope may be used to transport the elongate insertion shaft).
Regarding claim 9, Hradetzky discloses the surgical material delivery system of claim 1, further comprising a third electrode comprising a pad connectable to an electrical generator via a third conductor (see Fig. 5, showing two electrodes in the form of a second positive electrode associated with P and third electrode associated with P ' a first pair of first and second electrodes P; these electrodes are shown in Fig. 5 to be pad-shaped and are presumed to be connected to the same electrical generator 300 shown in Fig. 2 via conductive wiring), wherein the pad comprises a plurality of conducting zones, each conducting zone independently activatable to produce an electric field (see conducting zones 31a and 32a).
Regarding claim 10, Hradetzky discloses the surgical material delivery system of claim 1, further comprising a third electrode comprising a pad connectable to an electrical generator via a third conductor, wherein the pad comprise a two-dimensional or three-dimensional shape configured to correspond to an anatomic shape. (see Fig. 5, showing two electrodes in the form of a second positive electrode associated with P and third electrode associated with P ' a first pair of first and second electrodes P; these electrodes are shown in Fig. 5 to be pad-shaped and are presumed to be connected to the same electrical generator 300 shown in Fig. 2 via conductive wiring; further, these pads would conform to a flat anatomic shape).
Regarding claim 13, Hradetzky discloses the surgical material delivery system of claim 1, further comprising: an electrical generator 300 coupled to the first electrode and the second electrode to impart opposite charges to the first electrode and the second electrode (see positive and negative potentials, indicated in Fig. 3, applied to electrodes 100 and 200);
a surgical material reservoir 10 (see Fig. 3) fluidly connected to the passageway; and a propulsion system fluidly connected to the surgical material reservoir (see col. 10, lines 25-26, disclosing that the reservoir 10 is connected to a syringe pump that propels fluid along spraying direction S).
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.
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Hradetzky in view of Long (U.S. Pub. 2002/0147447, hereinafter "Long").
Regarding claim 5, it is noted that Hradetzky does not appear to disclose that the second electrode comprises wherein the second electrode comprises: a wire having an extension portion and a distal tip; and an insulation jacket extending along the extension portion to leave the distal tip exposed; wherein the distal tip includes a collapsible pad.
Long discloses an electrode for a medical system, comprising a wire 74 (see Fig. 12) having an extension portion 18 (see Fig. 12) and a distal tip 28 (see Fig. 12); and an insulation jacket extending along the extension portion to leave the distal tip exposed (see para [0049]; extension portion 18 comprises conductors that are electrically insulated from each other); wherein the distal tip includes a collapsible pad 28 (see Fig. 12 and para [0060]; the pad 28 can collapse into sled housing 76).
A skilled artisan would have found it obvious at the time of the invention to modify the device of Hradetzky to provide the second electrode with a wire having an extension portion and a distal tip; and an insulation jacket extending along the extension portion to leave the distal tip exposed; wherein the distal tip includes a collapsible pad, as a well-known structure that is able to provide controlled electrical charge to the tissue and withdrawn to stop the electrical charge as desired.
Regarding claim 6, Hradetzky discloses that the second electrode extends from a portion of the elongate insertion shaft distally of the discharge opening (see Fig. 1, showing electrode elements 200b and 200c extending slightly beyond the opening of 30), but does not appear to disclose a cap couplable to a distal end face of the elongate insertion shaft; wherein the cap comprises: a cylindrical body configured to circumscribe the elongate insertion shaft; and a side port extending through the cylindrical body to allow surgical material to pass therethrough.
Long discloses an electrode for a medical system, comprising a cap 116 coupled to a distal end face of an insertion shaft 63 (see Fig. 23), the cap comprising a cylindrical body that circumscribes the elongate insertion shaft and a side port 86 (see Fig. 23) extending through the cylindrical body to allow surgical material to pass therethrough (see para [0069]; side opening 86 allows fluid communication between endoscope 12 and the interior of the esophagus around ablation cap).
A skilled artisan would have found it obvious at the time of the invention to modify the device of Hradetzky to provide a cap couplable to a distal end face of the elongate insertion shaft; wherein the cap comprises: a cylindrical body configured to circumscribe the elongate insertion shaft; and a side port extending through the cylindrical body to allow surgical material to pass therethrough, in order to provide more controlled positioning of the surgical material, with a reasonable expectation of success.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Hradetzky in view of Hutchinson et al (U.S. Pat. 5,360,428, hereinafter "Hutchinson").
Regarding claim 8, it is noted that Hradetzky does not appear to disclose that the second electrode comprises a trocar device, wherein the trocar device comprises a tubular body into which the elongate insertion shaft is inserted.
But Hradetzky teaches that its device enables minimally invasive access to various organ systems (see col. 15, lines 51-53).
Further, Hutchinson discloses that minimally invasive procedures can be performed using a laparoscopic technique using a trocar device, which is a tubular body into which the instrument is inserted (see col. 1, lines 25-30).
Accordingly, a skilled artisan would have found it obvious at the time of the invention to modify the device of Hradetzky by providing a trocar device as part of the second electrode, the trocar device comprising a tubular body into which the elongate insertion shaft is inserted, as trocars were known to provide ports of openings for the introduction of the surgical material (see Hutchinson at col. 1, lines 25-30); and in making such a combination, a skilled artisan would have had a reasonable expectation of success.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Hradetzky in view of Coffee et al (U.S. Pat. 4,634,057, hereinafter "Coffee").
Regarding claim 11, it is noted that Hradetzky discloses the system of claim 1, wherein the passageway of the elongate insertion shaft is lined (see col. 6, lines 30-36), but does not disclose that the lining is PTFE.
Coffee discloses a metal electrode assembly 70 supported in an insulating PTFE housing (see col. 4, lines 40-60).
A skilled artisan would have found it obvious at the time of the invention to modify the device of Hradetzky by using PTFE as the lining of the elongate insertion shaft, with a reasonable expectation of success in insulating the electrode assembly.
Further, the selection of a known material based on its suitability for its intended use can support a prima facie obviousness determination. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). In this case, PTFE was a known material suitable for insulation of electrodes.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Hradetzky in view of Woloszko (U.S. Pat. 6,837,884, hereinafter "Woloszko").
Regarding claim 12, it is noted that Hradetzky does not appear to disclose that the surgical material delivery system comprises a conducting gel comprising electrically chargeable particles.
Woloszko discloses that an electrosurgical apparatus, in the analogous art to Applicant's invention, may use electrically conductive gel at the target site prior to delivery of a high frequency voltage (see col. 4, line 64 to col. 5, line 12 and col. 20, lines 11-24).
A skilled artisan would have found it obvious at the time of the invention to modify the device of Hradetzky by providing a conducting gel comprising electrically chargeable particles as part of the surgical material delivery system, in order to achieve an improved current flow path between the first and second electrodes (as taught in Woloszko at col. 20, lines 11-13), with a reasonable expectation of success.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See Notice of References Cited.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SCOTT J MEDWAY whose telephone number is (571)270-3656. The examiner can normally be reached Monday through Friday, 8: 30 AM to 5: 00 PM.
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/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783 04/14/2026
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