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 .
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.
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.
Claims 1-3, 5, and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Atwell (US 2017/0333114) in view of Eggers et al. (US 5,683,366).
Regarding claim 1, Atwell teaches a system for incising tissue (see Figs. 1-5), comprising: an elongate electrode (see electrode 9; [0032], Figs. 1-2), the elongate electrode configured to flex (see flexible central portion 15; [0031], Fig. 2) to incise the tissue (see [0032]); an electrical energy source operatively coupled to the elongate electrode and configured to provide electrical energy to the elongate electrode (see “connection means for connecting the tissue treatment element to a source of electrosurgical energy”, [0004]); a tensioning element operatively coupled to the elongate electrode (see pivot pins 13 and 14 with linkages 11 and 12, Fig. 2; see also stiffer portions 16 & 17 adjacent each arm; [0031], Fig. 2), the tensioning element configured to provide tension to the elongate electrode to allow the elongate electrode to flex in response to the elongate electrode engaging the tissue and generating the incision (see “separation of the distal ends of the arms 4 causes the wire electrode 9 to be stretched”, “flexible central portion 15”; [0030]-[0031], Figs. 1 and 2); and a contact surface operatively coupled to the elongate electrode (see inner surfaces and distal facing surfaces of rotatable mountings 18 as shown in Fig. 2), the contact surface configured to engage a portion the tissue to shape the tissue prior to incising the tissue with the elongate electrode (the inner and distal surfaces of rotatable mountings 18 are configured to apply mechanical force to shape tissue prior to incising with the electrode when tissue is on the inside of the arms, outside of the arms, or both). However, Atwell fails to reasonably teach generating a plasma to incise the tissue and the electrical energy source configured to provide electrical energy to the electrode to generate the plasma as claimed.
Eggers teaches an electrosurgical device (see Figs. 15-16) comprising an energy source (see power supply 28, Fig. 1) configured to supply electrical energy to an electrode for the purpose of generating plasma to vaporize tissue (see col. 11, lines 39-54) to vaporize tissue (see col. 12, lines 12-16) for the purpose of ablation and cutting of body structures (see col. 3, lines 49-53). Therefore, it would have been obvious to one of ordinary skill in the art before the time of filing to have modified the energy source as taught by Atwell to be configured to provide electrical energy to generate plasma and provide for the plasma generation associated functionality recited in the claim in light of Eggers, the motivation being to provide the additional benefit of ablation of tissue of a thin layer of tissue while limiting the amount of heat transfer to surrounding tissue (see Eggers col. 12, lines 22-32).
Regarding claim 2, Atwell in view of Eggers further teaches a plurality of arms operatively coupled to the elongate electrode and the tensioning element (see Atwell: first and second arms 4 as shown in Figs. 1 and 2, see also [0030]-[0031]).
Regarding claim 3, Atwell further teaches wherein the elongate electrode is unsupported between at least two of the plurality of arms (as shown in Fig. 2).
Regarding claim 5, Atwell further discloses wherein the contact surface comprises a first contact surface having a first surface profile (see surface profile of the inner surface of rotatable mountings 18, Fig. 2) and a second contact surface having a second surface profile (see surface profile of distal facing surfaces of rotatable mountings 18, Fig. 2), a difference between the first surface profile and the second surface profile corresponding to a shape profile of a volume of tissue to be removed (the profile of the surfaces are different as shown in Fig. 2, which each correspond to a different shape profile when incising/removing tissue that is mechanically pressured by the respective surface profiles).
Regarding claim 7, Atwell in view of Eggers further teaches wherein the tissue comprises ocular tissue (since the intended use of the system as claimed is “for incising ocular tissue” when read in combination with claim 1, and the device of Atwell in view of Eggers would reasonably be capable of incising ocular tissue using the plasma generated by the device, the device of Atwell in view of Eggers meets the claim).
Regarding claim 12, Atwell in view of Eggers teaches the limitations of claim 1, however fails to specifically teach wherein: a length of the elongate electrode is within a range from about 6mm to about 12mm; the elongate electrode comprises a wire having a diameter within a range from about 5µm to about 20µm; and wherein the tensioning element is configured to provide a tension to the elongate electrode within a range from about 100mN to about 500mN.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the electrode of Atwell in view of Eggers to have a length of the elongate electrode is within a range from about 6mm to about 12mm and a wire having a diameter within a range from about 5µm to about 20µm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Atwell in view of Eggers would not operate differently with the claimed length and diameter since the electrode would operate adequately for flexing and incising as intended. Further, applicant places no criticality on the ranges claimed, indicating simply that the length and diameter are “about” within the claimed ranges (specification pp. [0230]).
Additionally, it would have been obvious to one having ordinary skill in the art before the time of filing to configure the tensioning element to provide a tension to the elongate electrode within a range from about 100mN to about 500mN to provide for a workable stiffness to pass through incised tissue in a precise manner dependent upon the material properties of the tissue incised, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. See MPEP 2144.05.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Atwell in view of Eggers and in further view of Johnson et al. (US 2019/0328377).
Regarding claim 4, Atwell in view of Eggers teaches the limitations of claim 2 as discussed above, however Atwell in view of Eggers fails to teach wherein the elongate electrode is configured to vibrate transversely to an elongate axis of the elongate electrode.
Johnson teaches an electrosurgical device (see Fig. 32, left configuration) comprising active electrode wires (see 3208, Fig. 32, left configuration; [0343]) that are configured to vibrate transversely to an elongate axis of the electrodes (see “vibrates perpendicularly”, [0344]). Therefore, it would have been obvious to one of ordinary skill in the art before the time of filing to have modified the elongate electrode as taught by Atwell in view of Eggers to be configured to vibrate transversely to an elongate axis of the elongate electrode in light of Johnson, the motivation being to speed the wire’s progress through tissue in the direction of travel (see Johnson [0201]).
Claims 6 and 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Atwell in view of Eggers and in further view of Hushka et al. (US 2009/0088739).
Regarding claims 6 and 8-10, Atwell in view of Eggers teaches the limitations of claim 1, however Atwell in view of Eggers fails to teach wherein the contact surface comprises a free-form optical surface; the contact surface comprises a deformable membrane; a sterile barrier for placement on the contact surface to maintain sterility of the tissue, and wherein the sterile barrier comprises a barrier configured to conform to the shape of the contact surface with the sterile barrier between the tissue and the contact surface.
Hushka teaches surgical system for conducting electrosurgical energy to tissue (see [0086] and Fig. 16) including a free-form surface that is reasonably capable of conforming to optical tissue forming a deformable membrane around the tissue contacting surfaces of the device, and forms a conformable, sterile barrier between the tissue and the tissue contacting surfaces of the end effector (see an insulating sheath or boot 1700 designed like a condom and filled with a silicone lube 1710, [0101]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the contact surface as taught by Atwell in view of Eggers to comprise a free-form optical surface, a deformable membrane, and a sterile barrier for placement on the contact surface to maintain sterility of the tissue, wherein the sterile barrier comprises a barrier configured to conform to the shape of the contact surface with the sterile barrier between the tissue and the contact surface in light of Hushka, the motivation being to provide the additional advantage of protecting the end effector before use (see Hushka [0101]).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,053,220. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of U.S. Patent No. 12,053,220 anticipate the claims of the application. Accordingly, the application claims are not patentably distinct from the patent claims. Here, the more specific patent claims encompass the broader application claims. Following the rationale in In re Goodman cited in the preceding paragraph, where applicant has once been granted a patent containing a claim for the specific narrow invention, applicant may not obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
Allowable Subject Matter
Claims 11 and 13-20 are rejected under the non-statutory double patenting rejection above, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims and submission of a proper terminal disclaimer to obviate the double patenting rejection above.
The following is a statement of reasons for the indication of allowable subject matter: The closest prior art references, Atwell (US PGPub 2017/0333114), Eggers et al. (US 5,683,366), Trees et al. (US 2015/0282822), and Hushka et al. (US 2009/0088739), fails to reasonably teach or suggest wherein the sterile barrier comprises a peel-and-stick sterile barrier, and a processor operatively coupled to the elongate electrode, the processor configured with instructions to advance the elongate electrode distally and draw the elongate electrode proximally when considered in combination with the additional requirements of the claims, respectively. The prior art teaches a incising tissue using a motor connected to an actuator to move a cutting device, as well as a sterile barrier placed over the end effector of a device, however when either considered alone or in any proper combination the prior art fails to specifically disclose or render obvious a processor with instructions to advance the elongate electrode distally and draw the elongate electrode proximally, or the sterile barrier for the contact surface being a peel and stick barrier specifically, any conclusion otherwise would require improper hindsight reasoning.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN W COLLINS whose telephone number is (408)918-7607. The examiner can normally be reached M-F 9:00 AM-5:00 PM ET.
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/SEAN W COLLINS/Primary Examiner, Art Unit 3794
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