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 statements (IDS) submitted on January 1, 2024, April 3, 2024, and October 3, 2024 are acknowledged. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 410, 490, 550, 560, 580, 582, 584, 588, 644, 650, 660, 680, 682, 684, 688, 780, 782, 784, 844, 850, 860, 870. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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. 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.
Claim Objections
Claim 12 is objected to because of the following informality: In line 1, “The radiofrequency-shaver electrosurgical instrument of clam 11” should read “The radiofrequency-shaver electrosurgical instrument of claim 11”. 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 4-14, 19 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.
Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The accepted meaning of the term “between” is “in the time, space, or interval that separates” (Merriam-Webster), but it appears the term “between” in at least Claims 5-13 and 19 is used in a less restrictive manner that also includes the space of the two objects or regions being used as reference themselves.
The term “between” in Claims 5-13, and 19 is indefinite because the specification does not clearly redefine the term. More particularly, Claim 7 requires a thermal barrier formed “between the outer shaft and an outer electrical insulating layer”, but Claims 8 and 19 require the thermal barrier of claim 7 to comprise “a polymer sleeve which forms the outer electrical insulating layer”. To reconcile the claims, it is necessary to interpret the word “between” in the less restrictive definition suggested above such that the region “between the outer shaft and an outer electrical insulating layer” includes the outer shaft and outer electrical insulating layer. Claim 10, which limits the thermal barrier to be “between the inner shaft and the central suction lumen”, likewise requires the suggested less restrictive definition because the inner shaft defines the central suction lumen. The same issue occurs when trying to reconcile Claim 5 (and by virtue of dependency, Claims 6, 9, 11 and 13), which requires the thermal barrier to be formed between the inner shaft and the outer shaft, and Claim 12, which requires the thermal barrier of Claim 5 to comprise the central suction lumen. As such, for the purpose of the examination of those claims, the area “between” will be understood to include that of the two objects or regions being referenced as well as the space separating them.
Additionally, Claim 4 recites the limitation "the at least one air gap”" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Lastly, the term “irregular shaped” in Claim 14 is a term which renders the claim indefinite due to the meaning of the term being unclear. The term “irregular shaped” is not defined by the claim, the specification does not provide a standard for ascertaining the meaning of the term, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For the purpose of examination, “irregular shaped” will be understood to mean any shape that is not symmetrical about both a horizontal and vertical axis.
Claim Rejections - 35 USC § 102
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, 3, 5-8, 10-13, 15-18 and 20 are rejected under 35 U.S.C. 102(a)(1) as being taught by US 20190015151 A1 (Germain et al.).
Regarding Claim 1, Germain teaches a radio-frequency shaver electrosurgical instrument (see Fig. 1) comprising: an outer shaft [422] and a relatively rotatable inner shaft [412] (see Figs. 10 and 12A-C; see also para. 0063, "The inner sleeve 412 is operatively coupled to a motor drive 105 and rotates in an outer sleeve 422"), the outer and inner shafts having cutting windows [415] disposed at the distal end thereof, the inner shaft [412] comprising a central suction lumen [420] which, in use, evacuates liquid from the distal end of the electrosurgical instrument (see Figs. 12A-C; see also para 0071, "tissue debris, fragments, detritus and byproducts will be aspirated along with fluid 486 through the window 415 and outwardly through the interior extraction channel 420"); and a radiofrequency active electrode [425] located at the distal end of the electrosurgical instrument; wherein the radio-frequency shaver electrosurgical instrument further comprises a thermal barrier (e.g., [892]) located between the central suction lumen and an outer surface of the radiofrequency-shaver electrosurgical instrument, the thermal barrier being disposed around a major portion of the angular extent of the central suction lumen (see Fig. 21; see also para. 0093, "the outer and inner sleeves, 870 and 875, are separated by insulator layers").
Regarding Claim 3, Germain teaches the thermal barrier comprises one or more of the following: a polymer sleeve, a polymer shaft and a steel shaft (see para. 0094, "The inner sleeve 875 similarly has a heat shrink polymer layer 892 over its outer surface which electrically separates the inner sleeve 875 from the outer sleeve 870 throughout the length of the shaft 855" and para. 0064, “the outer sleeve 422 can comprise an electrically conductive material such as stainless steel . . . [and] is optionally covered by a thin insulating layer 448, such as . . . a chemical vapor deposited poly(p-xylylene) polymer”)
Regarding Claim 5, Germain teaches the thermal barrier [892] is formed between the inner shaft [875] and the outer shaft [870] (see Fig. 21).
Regarding Claim 6, Germain teaches the thermal barrier comprises a polymer sleeve [892] surrounding the inner shaft [875] (see Fig. 21).
Regarding Claims 7, Germain teaches the thermal barrier is formed between the outer shaft [870] and an outer electrical insulating layer [890] (see Fig. 21; see also para. 0094. "The outer sleeve 870 has an exterior insulating layer 890, such as a heat shrink polymer").
Regarding Claim 8, Germain teaches the thermal barrier comprises a polymer sleeve [890] which forms the outer electrical insulating layer (see para. 0094, "The outer sleeve 870 has an exterior insulating layer 890, such as a heat shrink polymer").
Regarding Claim 10, Germain teaches the thermal barrier is formed between the inner shaft [122] and the central suction lumen [165] (inner shaft acting as a thermal barrier) (see Fig. 10; see also para. 0046 “The outer and inner sleeves 120 and 122 typically can be a thin wall stainless steel tube).
Regarding Claim 11, Germain teaches the thermal barrier comprises a steel shaft [122] or a polymer shaft [892] (see Fig. 10; see also para. 0046 “The outer and inner sleeves 120 and 122 typically can be a thin wall stainless steel tube).
Regarding Claim 12, Germain teaches the steel or polymer shaft [122] comprises the central suction lumen [165] (see Fig. 2; see also para. 0046, "The outer and inner sleeves 120 and 122 typically can be a thin wall stainless steel tube").
Regarding Claim 13, Germain teaches the steel or polymer shaft is self-supported (see Fig. 2 and Fig. 21 wherein the shafts do not share stiffening ribs for support but rather each protrude from the handpiece independently).
Regarding Claim 15, Germain teaches the thermal barrier [122] is disposed around the entirety of the angular extent of the central suction lumen (see Fig. 2)
Regarding Claim 16, Germain teaches that rotation of the inner shaft within the outer shaft causes a tissue cutting action of the cutting window of the inner shaft interacting with the cutting window of the outer shaft. (compare Figs. 12A-C, see also Figs. 5A-B)
Regarding Claim 17, Germain teaches an operative shaft having RF electrical connections operably connected to the radiofrequency active electrode (see para. 0064, “the ceramic member 405 carries an electrode arrangement 425, or active electrode, having a single polarity that is operatively connected to an RF source 440”).
Regarding Claim 18, Germain teaches the operative shaft further comprises drive componentry [828] operably connected to a rotary shaver arrangement, the rotary shaver arrangement comprising the outer shaft and the inner shaft, to drive the rotary shaver arrangement to operate in use (see para. 0063, “The inner sleeve 412 is operatively coupled to a motor drive 105 and rotates in an outer sleeve 422”).
Regarding Claim 20, Germain teaches an electrosurgical system, comprising: an RF electrosurgical generator [830] (see Fig. 18); a suction pump [835A-B] (see Fig. 18); radio-frequency shaver electrosurgical instrument (see Fig. 1) comprising: an outer shaft [422] and a relatively rotatable inner shaft [412] (see Figs. 10 and 12A-C; see also para. 0063, "The inner sleeve 412 is operatively coupled to a motor drive 105 and rotates in an outer sleeve 422"), the outer and inner shafts having cutting windows [415] disposed at the distal end thereof, the inner shaft [412] comprising a central suction lumen [420] which, in use, evacuates liquid from the distal end of the electrosurgical instrument (see Figs. 12A-C; see also para 0071, "tissue debris, fragments, detritus and byproducts will be aspirated along with fluid 486 through the window 415 and outwardly through the interior extraction channel 420"); and a radiofrequency active electrode [425] located at the distal end of the electrosurgical instrument; wherein the radio-frequency shaver electrosurgical instrument further comprises a thermal barrier (e.g., [892]) located between the central suction lumen and an outer surface of the radiofrequency-shaver electrosurgical instrument, the thermal barrier being disposed around a major portion of the angular extent of the central suction lumen (see Fig. 21; see also para. 0093. "the outer and inner sleeves, 870 and 875, are separated by insulator layers"), and an operative shaft [804] having RF electrical connections [845A-B] operably connected to the radiofrequency active electrode the arrangement of the electrosurgical system being such that in use the RF electrosurgical generator [830] supplies an RF coagulation or ablation signal via the RF electrical connections [845A-B] to the radiofrequency active electrode [425], and the suction pump [835A-B] supplies suction via the central suction lumen [420] connecting the suction aperture located within the electrode to the suction pump (see Fig. 19; see also para. 0073, “a method corresponding to the invention includes providing an elongated shaft with a working end 400 comprising an active electrode 425 carried adjacent to a window 415 that opens to an interior channel in the shaft which is connected to a negative pressure source, positioning the active electrode and window in contact with targeted tissue in a fluid-filled space, activating the negative pressure source to thereby suction targeted tissue into the window and delivering RF energy to the active electrode to ablate tissue while translating the working end across the targeted tissue”).
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 2 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over US 20190015151 A1 (Germain et al.).
Regarding Claim 2, Germain does not specifically disclose a thermal barrier comprising at least one air gap between the central suction lumen and an outer surface of the device, but does disclose a thermal barrier comprising an air gap [1220] surrounding the lumen located in the handpiece [1200] (see Fig. 23; see also para. 0103, "the outflow sleeve 1210 has a dimension that provides for a surrounding air gap 1220 between the outer wall surface 1222 of sleeve 1210 and the wall of 1225 bore 1205. The air gap 1220 thus provides a significant insulator layer which can prevent heat transfer from any fluid in the outflow sleeve 1210 to the handpiece body 1202"). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Germain to provide an air gap between the central suction lumen and an outer surface of the device. Doing so would similarly reduce any excessive heat transfer between the hot fluids in the central suction lumen and the outer surface of the device.
Regarding Claim 4, Germain does not disclose the thermal barrier comprising a polymer sleeve, polymer shaft and/or steel shaft that encloses one or more pockets of air to form the at least one air gap between (a) the polymer sleeve, polymer shaft and/or steel shaft and (b) the inner shaft or the outer shaft around the central suction lumen. However, Germain does disclose a wall [1225] of shaft [1205] enclosing an air gap [1220] around the outer surface of polymer sleeve [1210] that surrounds the lumen located in the handpiece [1200] (see Fig. 23; see also para. 0103, "the outflow sleeve 1210 has a dimension that provides for a surrounding air gap 1220 between the outer wall surface 1222 of sleeve 1210 and the wall of 1225 bore 1205. The air gap 1220 thus provides a significant insulator layer which can prevent heat transfer from any fluid in the outflow sleeve 1210 to the handpiece body 1202"). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Germain to provide an air gap between the central suction lumen and an outer surface of the device. Doing so would similarly reduce any excessive heat transfer between the hot fluids in the central suction lumen and the outer surface of the device like in the handpiece.
Claims 9 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over US 20190015151 A1 (Germain et al.) in view of WO 2012142217 A1 (Curley).
Regarding Claims 9 and 19, Germain does not disclose the thermal barrier comprising stiffening ribs between the outer shaft and the polymer sleeve. However, Curley discloses a thermal barrier comprising stiffening ribs [922] between an outer elongate body [802] and inner tube [920] (see page 27, lines 10-14, “When placed within the inner lumen 806 of the elongate body 802, the tabs 922 can prevent the insulating tube 920 from directly contacting the sidewalls of the elongate body. As a result, an air gap 924 can be created between the thermocouple 812 or other temperature sensor and the insulating tube 920 containing heated fluid for use in fluid enhanced ablation.”). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Germain in view of Curley to provide a thermal barrier comprising stiffening ribs between the outer shaft and the polymer sleeve. Doing so would introduce insulating air gaps between the shaft and sleeve in order to further reduce excessive heat transfer from the heated fluids to the outer surface of the device in a similar way as the device of Curley.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over US 20190015151 A1 (Germain et al.) in view of US 20220395320 A1 (Carlson et al.).
Regarding Claim 14, Germain teaches a device with a channel in an outer shaft arranged to guide a radiofrequency wire [465] delivering energy to the active electrode [425] (see Fig. 10) but does not disclose the outer shaft having an irregular shaped cross-section. Carlson teaches a shaft having an irregular shaped cross-section arranged that is arranged to guide wires therein (see Fig. 3A; see also para. 0032, “channel 140 may be sized to receive a wire bundle”). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Germain in view of Carlson to provide an irregular shaped cross-section to guide the RF wire. Doing so could provide the necessary support for the RF wire to reach the distal tip of the device as an alternative to the use of a dedicated lumen within the shaft.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTIAN M SARCENO ROBLES whose telephone number is (571)272-8786. The examiner can normally be reached M-F: 8:30AM - 5:00PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at (571) 272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.S./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794