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.
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 11-17 and 19-20 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5-7, 10, and 13-14 of U.S. Patent No. 12,251,341. Although the claims at issue are not identical, they are not patentably distinct from each other because the limitations of examined claims 11-17 and 19-20 would have been obvious over reference claims 1-3, 5-7, 10, and 13-14 of Patent ‘341.
Regarding claim 11, Patent ‘341 claims a method of using a system for incising tissue with a plasma, comprising: an elongate electrode configured to incise the tissue along a tissue incision profile; and a tissue contact element configured to shape the tissue, the tissue contact element comprising one or more of a channel or a protrusion to form one or more of a corresponding protrusion or indentation in a tissue surface while the tissue is incised with the electrode along the incision profile, wherein the tissue contact element shapes the tissue sufficiently to allow the tissue to form one or more complimentary features along the incision profile when the tissue relaxes to a free-standing configuration with removal of the tissue contact element (see reference claim 1).
Regarding claim 12, Patent ‘341 claims wherein the one or more complimentary features comprises a protrusion on a first side of the tissue incision profile and an indentation on a second side of the incision profile to stabilize the tissue in the free-standing configuration at an interface between the first side and the second of the tissue incision profile (see reference claim 2).
Regarding claim 13, Patent ‘341 claims wherein the tissue incision profile defines a first portion of tissue on a first side of the incision profile and a second portion on a second side of the tissue incision profile and wherein the first portion comprises the protrusion and the second portion comprises a corresponding indentation sized and shaped to receive the protrusion (see reference claim 3).
Regarding claim 14, Patent ‘341 claims wherein the first portion comprises the tissue surface and the second portion comprises a bed of tissue (see reference claim 5).
Regarding claim 15, Patent ‘341 claims wherein the second portion comprises the tissue surface and the first portion comprises a bed of tissue (see reference claim 6).
Regarding claim 16, Patent ‘341 claims wherein the one or more of the channel or the protrusion of the contact element comprises a channel and wherein the channel is sized to receive the tissue surface to form a corresponding protrusion and indentation along the tissue incision profile in the free-standing configuration (see reference claim 7).
Regarding claim 17, Patent ‘341 claims herein the one or more of the channel or the protrusion of the contact element comprises the protrusion and wherein the protrusion is sized to indent the tissue surface to form a corresponding protrusion and indentation along the tissue incision profile in the free-standing configuration (see reference claim 10).
Regarding claim 19, Patent ‘341 claims wherein the tissue incision profile comprises a linear incision profile when the tissue is incised with translation of the electrode (see reference claim 13).
Regarding claim 20, Patent ‘341 claims wherein the tissue incision profile comprises a two-dimensional linear incision profile when the tissue is engaged with the contact element and wherein the one or more complimentary features comprises a three-dimensional complimentary surface profile when the tissue has relaxed to the free-standing configuration (see reference claim 14).
Therefore, examined claims 11-17 and 19-20 are not patentably distinct from reference claims 1-3, 5-7, 10, and 13-14 of Patent ‘341.
This is a provisional nonstatutory double patenting rejection.
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) 11-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cunanan, (US 20070280994) in view of Spooner (US 20160074226).
Regarding claim 11, Cunanan (Figures 7E-9) discloses a system for incising tissue, comprising: an elongate electrode ([0032]: incision may be performed by thermal cutting devices, i.e. electrodes) configured to incise the tissue along a tissue incision profile shown in Figure 7E). Cunanan further discloses that that a microkeratome may be used to shape the tissue, but fails to disclose a tissue contact element comprising one or more of a channel or a protrusion to form one or more of a corresponding protrusion or indentation in a tissue surface while the tissue is incised with the electrode along the incision profile, wherein the tissue contact element shapes the tissue sufficiently to allow the tissue to form one or more complimentary features along the incision profile when the tissue relaxes to a free-standing configuration with removal of the tissue contact element. However, Spooner (Figures 1 and 5B) teaches a system for incising tissue by performing keratectomy, wherein shaping is done with a tissue contact plate comprising a tissue profile ([0096]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Cunanan to perform the shaping with the known method of using a tissue contact plate comprising a desired tissue profile, as taught by Spooner, to the base system disclosed by Cunnan, because the known method of using the tissue contact plate would have predictably resulted in the shaping of the tissue. Therefore, it would have been within the skill of the ordinary artisan to use a tissue contact plate comprising a desired tissue profile to shape the tissue. MPEP 2143.D. Furthermore, the desired tissue profile in the modified device would comprise one or more of a plurality of channels or a plurality of protrusions corresponding to the plurality of protrusions or a plurality of indentations in the tissue surface disclosed by Cunanan; and the modified device would include removing the contact plate to allow the tissue to relax to a free-standing configuration and form a plurality of complimentary features corresponding to the one or more of the plurality of channels or the plurality of protrusions of the tissue contact plate along the tissue incision profile.
Regarding claim 12, Cunanan (Figures 7E-9) further discloses wherein the one or more complimentary features comprises a protrusion on a first side (left element 110) of the tissue incision profile and an indentation on a second (ridge 131) side of the incision profile to stabilize the tissue in the free-standing configuration at an interface between the first side and the second of the tissue incision profile ([0038], [0050]-[0053]).
Regarding claim 13, Cunanan (Figures 7E-9) further discloses wherein the tissue incision profile defines a first portion of tissue on a first side (left element 110) of the incision profile and a second portion on a second (ridge 131) side of the incision profile and wherein the first portion comprises one or more protrusions (protrusions formed from the cutout of target tissue) and the second portion comprises one or more corresponding indentations (indentation formed from cutting the target tissue) sized and shaped to receive the one or more protrusions in the relaxed configuration ([0038], [0050]-[0053]).
Regarding claim 14, Cunanan (Figures 7E-9) further discloses wherein the first portion (110) comprises the tissue surface and the second portion (110’) comprises a bed of tissue ([0038], [0050]-[0053]).
Regarding claim 15, Cunanan (Figures 7E-9) further discloses wherein the second portion (110) comprises the tissue surface and the first portion (110’) comprises a bed of tissue ([0038], [0050]-[0053]).
Regarding claim 16, Cunanan (Figures 7E-9) further discloses wherein the one or more of the channel or the protrusion (110) of the contact element (120) comprises a channel (110) and wherein the channel is sized to receive the tissue surface to form a corresponding protrusion along the tissue incision profile in the free- standing configuration ([0038], [0050]-[0053]).
Regarding claim 17, Cunanan (Figures 7E-9) further discloses wherein the one or more of the channel or the protrusion (110) of the contact element (120) comprises the protrusion (110) and wherein the protrusion (110) is sized to indent the tissue surface to form a corresponding indentation along the tissue incision profile in the free-standing configuration ([0038], [0050]-[0053]).
Regarding claim 18, Cunanan (Figures 7E-9) further discloses an actuator to translate the electrode ([0032]: incision may be performed by thermal cutting devices, i.e. electrodes, which requires an actuator to move the electrode for incision)
Regarding claim 19, Cunanan (Figures 7E-9) further discloses wherein the incision profile comprises a linear incision profile when the tissue is incised with translation of the electrode, as shown in Figure 7E ([0038], [0050]-[0053]).
Regarding claim 20, Cunanan (Figures 7E-9) further discloses wherein the tissue incision profile comprises a two-dimensional linear incision profile when the tissue is engaged with the contact element and wherein the one or more complimentary features comprises a three-dimensional complimentary surface profile when the tissue has relaxed to the free-standing configuration. Cunanan (Figures 7E-9) further discloses wherein the incision profile comprises a two-dimensional linear incision profile when the tissue is engaged with the contact element (120) and wherein the plurality of complimentary features comprises a three-dimensional complimentary surface profile (the cutout profile) when the tissue has relaxed to the free-standing configuration, as shown in Figure 7E ([0038], [0050]-[0053]).
Regarding claim 21, Cunanan/Spooner further teaches wherein the tissue contact element ( tissue contact plate taught by Spooner) comprises an adjustable contact element configured to shape the tissue to a first surface profile to resect the tissue along a first tissue resection profile and to a second surface profile to resect the tissue along a second incision profile (tissue contact plate may be adjusted to resect a first surface profile at a first depth and a second surface profile at a second depth)
Regarding claim 22, Cunanan/Spooner further teaches wherein a difference between the first tissue resection profile and the second tissue resection profile defines a volume of resected tissue (between the two surface profiles at different depths).
Regarding claim 23, Cunanan/Spooner further teaches wherein the adjustable contact element (tissue contact plate taught by Spooner) comprises a first surface profile configuration (corresponding to the first surface profile at the first depth) to shape the tissue to the first surface profile and a second surface profile configuration (corresponding to the second surface profile at the second depth) to shape the tissue to the second surface profile configuration.
Regarding claim 24, Cunanan/Spooner further teaches the adjustable contact element (tissue contact plate taught by Spooner) comprises inner elements to define the first surface profile and the second surface profile (corresponding elements to the first and second profiles at different depths) and outer elements to define the one or more complimentary features (corresponding elements to the complimentary features).
Regarding claim 25, Cunanan/Spooner further teaches wherein the outer elements are configured to remain substantially fixed (the tissue contact plate taught by Spooner would have stationary outer elements corresponding to the complimentary features in order to define their shape) while the tissue is incised with advancement of the electrode (electrode disclosed by Cunanan) and retraction of the electrode and inner elements (by the user moving the device) are configured to shape the tissue to the first surface profile with a first configuration while the electrode is advanced (at a deeper depth) and to the second surface profile with a second configuration while the electrode is retracted (at a shallower depth).
Regarding claim 26, Cunanan (Figures 7E-9) further discloses wherein the one or more of the channel or the protrusion (110) comprises a channel (110) and wherein the channel is sized to receive the tissue surface to form a plurality of corresponding protrusions in the tissue surface and a plurality of corresponding complimentary features ([0038], [0050]-[0053]).
Regarding claim 27, Cunanan/Spooner further teaches a vacuum source coupled to the contact element to shape the tissue with the contact element (Spooner; [0028], [0096], [0270]).
Regarding claim 28, Cunanan/Spooner further teaches wherein the one or more of the channel or the protrusion comprises a channel coupled to the vacuum source to draw tissue into the channel to shape the tissue surface with a corresponding protrusion of the tissue surface (since the device is connected to a vacuum source as taught by Spooner, the one or more of the channel or the protrusion would comprise a vacuum channel coupled to the vacuum source to draw tissue into the channel).
Regarding claim 29, Spooner further teaches an electrical energy source ([0080]: source 200) operatively coupled to the elongate electrode (disclosed by Cunanan) and configured to provide electrical energy to the electrode to generate the plasma; and a tensioning element (200) operatively coupled to the elongate electrode, the tensioning element (200) 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 plasma ([0080]).
Regarding claim 30, Spooner further teaches a processor (270) operatively coupled to the elongate electrode (disclosed by Cunanan), the processor (270) configured to energize the elongate electrode while the contact plate shapes the tissue ([0182]-[0184]).
Conclusion
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/C.C.P./Examiner, Art Unit 3794
/EUN HWA KIM/Primary Examiner, Art Unit 3794
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