DETAILED ACTION
The following is a First Action, Non-Final Office Action on the merits.
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 .
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 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.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 16/725119, 15/383814 & 14/192978 provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
Accordingly, the claims are given the priority date of 2/28/2014.
Claim Objections
Claim 21 is objected to because of the following informalities: amend “as second” to -a second- in ll. 10. Appropriate correction is required.
Claim 21 is objected to because of the following informalities: amend “both aspiration apertures” to -both the first and second aspiration apertures- in ll. 10. Appropriate correction is required.
Claim 22 is objected to because of the following informalities: amend “edge are” to -edge surface are- in ll. 3. Appropriate correction is required.
Claim 22 is objected to because of the following informalities: amend “edges surfaces” to -edge surfaces- in ll. 4. Appropriate correction is required.
Claim 23 is objected to because of the following informalities: amend “different to” to -different from- in ll. 2. Appropriate correction is required.
Claim 25 is objected to because of the following informalities: amend “a peripheral edge surface” to -the peripheral edge surface- in ll. 3. Appropriate correction is required.
Claim 26 is objected to because of the following informalities: amend “offset from a longitudinal axis of the elongate shaft, offset towards the outer curved side” to -offset towards the outer curved side from a longitudinal axis of the elongate shaft- in ll. 5-6. Appropriate correction is required.
Claim 27 is objected to because of the following informalities: amend “spacer” to -spacer body- in ll. 1. Appropriate correction is required.
Claim 28 is objected to because of the following informalities: amend “spacer” to -spacer body- in ll. 1. Appropriate correction is required.
Claim 29 is objected to because of the following informalities: amend “spacer,” to -spacer body,- in ll. 9. Appropriate correction is required.
Claim 29 is objected to because of the following informalities: amend “the wand distal end portion” to -the elongate shaft distal end portion- in ll. 10. Appropriate correction is required.
Claim 29 is objected to because of the following informalities: amend “surface” to -surface portion- in ll. 12 & 13 (twice). Appropriate correction is required.
Claim 33 is objected to because of the following informalities: amend “offset from a longitudinal axis of the elongate shaft, offset towards the outer curved side” to -offset towards the outer curved side from a longitudinal axis of the elongate shaft-. Appropriate correction is required.
Claim 34 is objected to because of the following informalities: amend “spacer” to -spacer body- in ll. 1. Appropriate correction is required.
Claim 35 is objected to because of the following informalities: amend “spacer” to -spacer body- in ll. 1. Appropriate correction is required.
Claim 36 is objected to because of the following informalities: amend “the spacer body” to -the insulative spacer body- in ll. 11. Appropriate correction is required.
Claim 36 is objected to because of the following informalities: amend “as second” to -a second- in ll. 12. Appropriate correction is required.
Claim 36 is objected to because of the following informalities: amend “each aspiration aperture” to -each of the first and second aspiration apertures- in ll. 13. Appropriate correction is required.
Claim 37 is objected to because of the following informalities: amend “the aspiration aperture perimeter” to -the first and second aspiration apertures- in ll. 2-3. Appropriate correction is required. The claim will be interpreted in this manner as there is no support for the perimeter of the cavity aperture to be defined by the distal edge surface and u-shaped edge surface of the active electrode since it is part of the spacer body.
Claim 37 is objected to because of the following informalities: amend “the distal edge surface and the U-shaped edge surface” to -the U-shaped edge surface- in ll. 3-4 since the distal edge surface comprises the U-shaped edge surface. Appropriate correction is required.
Claim 39 is objected to because of the following informalities: amend “offset from a longitudinal axis of the elongate shaft, offset towards the outer curved side” to -offset towards the outer curved side from a longitudinal axis of the elongate shaft- in ll. 5-6. Appropriate correction is required.
Claim 40 is objected to because of the following informalities: amend “spacer” to -spacer body -in ll. 1. Appropriate correction is required.
Claim 40 is objected to because of the following informalities: amend “step projection” to -a step projection- in ll. 3. Appropriate correction is required.
Claim 40 is objected to because of the following informalities: delete the “,” in ll. 3. Appropriate correction is required.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 21-23, 25, 27-28, 36-37 & 40 is/are rejected under 35 U.S.C. 102(a)(1) or 102(a)(2) as being anticipated by Kramer et al. (2010/0160910).
Concerning claim 21, as illustrated in at least Figs. 1-17, Kramer et al. disclose an electrosurgical wand (electrosurgical tool 10; [0032]) comprising:
an elongate shaft having a handle end and a distal end portion (outer shaft 15; [0037]), the distal end portion comprising an active electrode (active electrode 17; [0032]), an insulative spacer body (insulator cap 57; [0038]) and a return electrode (exposed distal end 18 of the outer shaft 15 defines a return or reference electrode; [0032]), wherein the active electrode is supported on the insulative spacer body and is spaced distally from the return electrode (insulator cap 57 supports electrode 17 on a distal surface and insulates from the distal end 18 of outer shaft 15; [0038]);
wherein the insulative spacer body defines an aspiration cavity fluidly connected with an aspiration lumen, the aspiration cavity terminating with a cavity aperture defining a perimeter (cap 57 comprises bore 85 and bore 105 which connect to interior conduit 54; [0038], [0042], [0044], [0052]), and wherein the active electrode extends across and covers a portion of the aspiration cavity aperture (insulator cap 57 supports electrode 17 and covers bore 85; [0038], [0049]), defining a first aspiration aperture and as second aspiration aperture, both aspiration apertures bounded by the cavity aperture perimeter and a peripheral edge surface of the active electrode (suction openings 171 are bounded by the cavity aperture perimeter and peripheral edge(s) 128, 138, 132 of active electrode 17; [0045], [0055]).
Concerning claim 22, Kramer et al. disclose the active electrode (17) peripheral edge surface (128, 138, 132 ) defines a distal edge surface (128 and half of 138) and a proximal edge surface (132 and other half of 138), and wherein both the distal edge surface (128) and the proximal edge (132) are U-shaped edges surfaces that define a U-shaped boundary portion of the first and second aspiration aperture (171) ([0045]; Fig. 7).
Concerning claim 23, Kramer et al. disclose the first aspiration aperture (171) is different to the second aspiration aperture (171) ([0055]; Fig. 13 & 15).
Concerning claim 25, Kramer et al. disclose the first aspiration aperture (171) has an aspiration aperture perimeter bounded by the cavity aperture perimeter (132) and a peripheral edge surface (128, 138, 132 ) of the active electrode (17), the peripheral edge surface (128, 138, 132) defining a U-shaped portion of the first aspiration aperture (171) ([0045-0046]; Fig. 7 & 13) .
Concerning claim 27, Kramer et al. disclose the insulative spacer (57) includes a telescoping portion (90) that extends within an internal diameter of the return electrode (18) ([0043]; Fig. 6 & 10).
Concerning claim 28, Kramer et al. disclose the insulative spacer (57) includes a radial projection (92) configured to engage a distal edge of the return electrode (18) ([0043]; Fig. 10).
Concerning claim 36, as illustrated in at least Figs. 1-17, Kramer et al. disclose an electrosurgical wand (electrosurgical tool 10; [0032]) comprising:
an elongate shaft having a handle end and a distal end portion (outer shaft 15; [0037]), the distal end portion comprising an active electrode (active electrode 17; [0032]), an insulative spacer body (insulator cap 57; [0038]) and a return electrode (exposed distal end 18 of the outer shaft 15 defines a return or reference electrode; [0032]), wherein the active electrode is disposed on a distal surface of the insulative spacer body and is spaced away from the return electrode (insulator cap 57 supports electrode 17 on a distal surface and insulates from the distal end 18 of outer shaft 15; [0038]);
wherein the active electrode defines a peripheral edge surface defining distal and proximal edge surfaces (active electrode 17 comprises peripheral edge surface(s) distal: 128 & half of 138, proximal: 132 & other half of 138; [0045], [0055]);
wherein the insulative spacer body defines an aspiration cavity fluidly connected with an aspiration lumen and configured to aspirate fluid and plasma by-products therethrough, the aspiration cavity terminating on the distal surface of the spacer body defining a cavity aperture (cap 57 comprises bore 85 and bore 105 which connect to interior conduit 54; [0038], [0042], [0044], [0052]), and wherein the active electrode covers a portion of the cavity aperture (insulator cap 57 supports electrode 17 and covers bore 85; [0038], [0049]) to define a first and as second aspiration aperture, each aspiration aperture defined by the active electrode peripheral edge surface and a perimeter of the cavity aperture (suction openings 171 are bounded by the cavity aperture perimeter and peripheral edge(s) 128, 138, 132 of active electrode 17; [0045], [0055]).
Claim 37 is rejected upon the same rationale as applied to claim 22.
Claim 40 is rejected upon the same rationale as applied to claim 27-28.
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.
The factual inquiries 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.
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.
Claim(s) 24 & 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kramer et al. (2010/0160910), as applied to claim 21, in further view of Davison et al. (2003/0097129).
Concerning claim 24, while, Kramer discloses varying aspiration sized apertures (133, 171) ([0055]; Fig. 7), Kramer et al. fail to disclose the first aspiration aperture is smaller than the second aspiration aperture. However, Davison et al. disclose an electrosurgical wand comprising an active electrode having a plurality of aspiration ports coupled to a common aspiration channel, where the suction pressure of each working zone is a function of the number and size of the least one aspiration port in that zone, where the extent to which the active electrode(s) in each zone form a plasma is dependent, in part, on the local environment of that zone, wherein the local environment is determined by the aspiration rate. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Kramer et al. such that the first aspiration aperture is smaller than the second aspiration aperture in order to provide the benefit of controlling the relative rate of ablation as taught by Davison et al. ([0355-0356]).
Claim 38 is rejected upon the same rationale as applied to claim 24.
Claim(s) 26 & 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kramer et al. (2010/0160910), as applied to claim 21, in further view of Earley et al. (2006/0235377).
Concerning claim 26, Kramer et al. disclose the aspiration lumen (54) extends along the elongate shaft (15), the aspiration lumen (54) having a longitudinal axis that is offset from a longitudinal axis of the elongate shaft (15) (Fig. 6).
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The Examiner notes the claim fails to recite a “central” longitudinal axis.
Kramer et al. fail to disclose the elongate shaft includes a bend defining an outer curved side and an inner curved side of the elongate shaft. However, Earley et al. disclose an electrosurgical wand (10) having either a straight or bent configuration. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Kramer et al. such that the elongate shaft includes a bend defining an outer curved side and an inner curved side of the elongate shaft in order to provide the benefit of gaining better access to targeted tissue at the surgical site as taught by Earley et al. ([0046]; Fig. 1 & 11) The modified invention of Kramer et al. in view of Earley et al. teaches wherein the aspiration lumen extends along the elongate shaft including along the bend, the aspiration lumen having a longitudinal axis that is offset from a longitudinal axis of the elongate shaft, offset towards the outer curved side.
Claim 39 is rejected upon the same rationale as applied to claim 24.
Claim(s) 29-30 & 32-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kramer et al. (2010/0160910) in view of Earley et al. (2006/0235377).
Concerning claim 29, as illustrated in at least Figs. 1-17, Kramer et al. disclose an electrosurgical wand (electrosurgical tool 10; [0032]) comprising:
an elongate shaft having a handle end and a distal end portion (outer shaft 15; [0037]), the distal end portion comprising an active electrode (active electrode 17; [0032]), an insulative spacer body (insulator cap 57; [0038]) and a return electrode (exposed distal end 18 of the outer shaft 15 defines a return or reference electrode; [0032]), wherein the active electrode is disposed on a distal planar surface of the insulative spacer body and is spaced away from the return electrode (insulator cap 57 supports electrode 17 on a distal planar surface and insulates from the distal end 18 of outer shaft 15; [0038]);
wherein the active electrode comprises a peripheral edge surface defining distal and proximal medial edge surface portions (active electrode 17 comprises peripheral medial edge surface(s) distal: 128 & half of 138, proximal: 132 & other half of 138; [0045], [0055]);
wherein the insulative spacer body defines an aspiration cavity having an opening through the distal planar surface of the insulative spacer, the opening defining a perimeter (cap 57 comprises bore 85 through the distal planar surface and bore 105 which connect to interior conduit 54; [0038], [0042], [0044], [0052]); and wherein the wand distal end portion includes a first and a second aspiration aperture, the first aspiration aperture bounded by the distal medial edge surface of the active electrode and a distal portion of the opening perimeter and the second aspiration aperture bounded by the proximal medial edge surface of the active electrode and a proximal portion of the opening perimeter (suction openings 171 are bounded by distal and proximal portions of the cavity aperture perimeter and peripheral medical edge surfaces 128, 138, 132 of active electrode 17; [0045], [0055]).
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Kramer et al. fail to disclose the active electrode disposed on a distal-most planar surface. However, Earley et al. disclose an electrosurgical wand (10) having an active electrode disposed on a distal planar surface that is oriented in either a perpendicular position, such that the active electrode is disposed on a distal-most planar surface, or parallel position, such that the active electrode is disposed on a distal planar surface, with respect to a longitudinal axis of the device. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Kramer et al. such that the active electrode is disposed on a distal-most planar surface in order to provide the benefit of gaining better access to targeted tissue at the surgical site as taught by Earley et al. ([0039], [0046], [0055]; Fig. 6-7 & 14-18) and thereby providing the predictable result of treating tissue at the surgical site.
Concerning claim 30, Kramer et al. disclose the proximal and distal medial edge surface portions (128, 138, 132) each define a U-shaped portion (see annotated Fig. above).
Claim 32 is rejected upon the same rationale as provided for claim 25.
Claim 33 is rejected upon the same rationale as provided for claim 26.
Claim 34 is rejected upon the same rationale as provided for claim 27.
Claim 35 is rejected upon the same rationale as provided for claim 28.
Claim(s) 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kramer et al. (2010/0160910) in view of Earley et al. (2006/0235377), as applied to claim 29, in further view of Davison et al. (2003/0097129).
Concerning claim 31, while Kramer discloses varying aspiration sized apertures (133, 171) ([0055]; Fig. 7), Kramer et al. in view of Earley et al. fail to disclose the first aspiration aperture extends a first distance from the distal medial edge surface portion and the second aspiration aperture extends a second distance from the proximal medial edge surface portion of the active electrode, the first distance different from the second distance, such that the first and second aspiration apertures of different sizes. However, Davison et al. disclose an electrosurgical wand comprising an active electrode having a plurality of aspiration ports coupled to a common aspiration channel, where the suction pressure of each working zone is a function of the number and size of the least one aspiration port in that zone, where the extent to which the active electrode(s) in each zone form a plasma is dependent, in part, on the local environment of that zone, wherein the local environment is determined by the aspiration rate. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Kramer et al. in view of Earley et al. such that the first aspiration aperture extends a first distance from the distal medial edge surface portion and the second aspiration aperture extends a second distance from the proximal medial edge surface portion of the active electrode, the first distance different from the second distance, such that the first and second aspiration apertures of different sizes in order to provide the benefit of controlling the relative rate of ablation as taught by Davison et al. ([0355-0356]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Sharkey et al. (2002/0049438) teach a pre-bent shaft angle to optimize access to a particular body position or part for a desired surgical procedure and corresponding ablation effect ([0092]).
Thomas et al. (2009/0048592) teach an active electrode with a peripheral suction aperture (Fig. 3).
Davison et al. (2003/0097129) teach an active electrode screen having a plurality of apertures (Fig. 80B) and various shaft bend angles (Col. 18, ll. 28-38).
Aluru et al. (2014/0200581) teach an active electrode having apertures formed by the active electrode peripheral edge surface and an insulative body spacer (Fig. 3), but is not regarded as prior art under the exception of 102(b)(2)(C).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAYMI E DELLA whose telephone number is (571)270-1429. The examiner can normally be reached on M-Th 6:00 am - 4:45 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne 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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/JAYMI E DELLA/Primary Examiner, Art Unit 3794
JAYMI E. DELLA
Primary Examiner
Art Unit 3794