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 .
Response to Arguments
Applicant's arguments filed March 9th, 2026 have been fully considered but they are not persuasive. Applicant’s argument that their specification provides sufficient support to overcome the new matter rejection of claims 3-5 and 14-16 is not found persuasive. The Examiner notes that Applicant is citing paragraphs 37 and 63-64 of the specification which are a “laundry list” disclosure of potential configuration. A “laundry list” does not constitute a written description of every species in a genus because it would not “reasonably lead” those skill in the art to any particular species. See MPEP 2163.03. The mere general statement of mixing embodiments is not an express teaching of a singular species. In this instance, mixing embodiments of surface features of the ultrasonic blade, specifically the dimple configuration with the one or more helically stretching radial grooves and the dimple configuration with the use of two radial grooves extending in different directions. Further, Applicant argues that the dimples of Houser are not arranged in an offset patter, and are not arranged around the outer circumference which is transverse to a longitudinal axis and do not extend between a proximal end and a distal end. The Examiner respectfully disagrees with this assertion. The dimples are radially and circumferentially offset from one another as is taught in figures 18-22 as well as at least some of the dimples are longitudinally spaced from each other between a proximal and distal end.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 3-5 and 14-16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Regarding claims 3 and 14, Applicant claims the at least one incorporated feature includes one or more perpendicular radial groove stretching along and around the circumference of the ultrasonic blade, wherein edges of the grooves have abrasive surfaces. However, independent claims 1 and 12 require the at least one incorporated surface includes an offset pattern of embedded dimples. It appears Applicant is mixing embodiments which is precluded as there is no disclosure in the specification of mixing embodiments, specifically the dimple configuration with the one or more perpendicular radial grooves.
Regarding claim 4, Applicant claims the at least one incorporated feature includes one or more radial groove stretching helically along and around the circumference of the ultrasonic blade, wherein edges of the grooves have abrasive surfaces. However, independent claims 1 and 12 require the at least one incorporated surface includes an offset pattern of embedded dimples. It appears Applicant is mixing embodiments which is precluded as there is no disclosure in the specification of mixing embodiments, specifically the dimple configuration with the one or more helically stretching radial grooves.
Regarding claim 15, Applicant claims the at least one incorporated feature includes a single radial groove stretching helically along and around the circumference of the ultrasonic blade, wherein edges of the grooves have abrasive surfaces. However, independent claims 1 and 12 require the at least one incorporated surface includes an offset pattern of embedded dimples. It appears Applicant is mixing embodiments which is precluded as there is no disclosure in the specification of mixing embodiments, specifically the dimple configuration with the single helically stretching radial grooves. Regarding claims 5 and 16, Applicant claims the at least one incorporated feature includes a first radial groove stretching helically along and around the circumference of the ultrasonic blade in a first direction; and a second radial groove stretching helically along and around the circumference of the ultrasonic blade in a second direction, wherein the first and second radial grooves intersect and create crossed spiral grooves, wherein the edges of the grooves have abrasive surfaces. However, independent claims 1 and 12 require the at least one incorporated surface includes an offset pattern of embedded dimples. It appears Applicant is mixing embodiments which is precluded as there is no disclosure in the specification of mixing embodiments, specifically the dimple configuration with the use of two radial grooves extending in different directions.
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 1, 3-4, 6-9, 11-15 and 17-23 are rejected under 35 U.S.C. 103 as being unpatentable over Onuma et al. (US 2016/0157884) in view of Houser (US 2008/0234709).
Regarding claim 1, Onuma et al. disclose a surgical instrument, comprising an ultrasonic transducer (22) contained in a housing (21); a transmission assembly (26), at least partially received by the housing (figure 2) and encapsulating a waveguide (28a. ¶32, ¶41), wherein the waveguide is configured to transmit ultrasonic vibrations from the transducer to the ultrasonic blade (¶32, ¶41); the ultrasonic blade including a blade tip (15) and at least one incorporated feature (figures 3-16) between a distal end of the ultrasonic blade and a proximal end, wherein the at least one incorporated feature includes one or more depressions or protrusions (see figure below/65), forming abrasive surfaces (66)and channels (see figure below, the respective surface which forms the edge between the depressions and protrusions/65 and 68), wherein the abrasive surfaces breakup tissue and the channels expel the broken-up tissue (¶5, ¶41-42, ¶47,¶63, ¶66, ¶74, ¶78), the at least one incorporated feature includes an offset pattern of embedded dimples (see figure below, dimples are longitudinally offset about axis “C”), wherein the edges of the dimples have abrasive surfaces (see figure below); and a control switch (18) operable to initiate and halt the ultrasonic transducer (¶41).
However, Onuma et al. fails to expressly teach or disclose the offset pattern of embedded dimples extend around an outer circumference of the blade tip, the circumference being transverse to a longitudinal axis of the blade tip extending between the proximal end and the distal end, wherein the edges comprise closed circles.
Houser discloses an ultrasonic blade (600,figures 21-22) having at least one incorporated feature (650’s), wherein the at least one incorporated feature includes a plurality of offset dimples (650’s, figures 21-22 are circumferentially offset) extending around an outer circumference of the blade tip (figures 21-22), wherein edges of the at least one incorporated feature comprise closed circles (figures 21-22) and have abrasive surfaces (652, figure 22, ¶73) as it is a known alternative construct for forming a tissue cutting edge to form and shape tissue and also assist in the removal of cortical bone (¶73).
Accordingly, it would have been obvious to one of ordinary skill in the art at the time of filing to have constructed the at least one incorporated feature to include plurality of offset dimples extending around an outer circumference of the blade tip, wherein edges of the at least one incorporated feature comprise closed circles and have abrasive surfaces as taught by Houser as having closed circle dimples is a known alternative construct for forming a tissue cutting edge to form and shape tissue and also assist in the removal of cortical bone.
Regarding claim 3, Onuma et al. disclose the at least one incorporated feature includes one or more perpendicular radial grooves (78’s) stretching along and around the circumference of the ultrasonic blade, wherein the edges of the grooves have abrasive surfaces (where the outer surface 79 and the radial groove wall meet to form an edge).
Regarding claim 4, Onuma et al. disclose the at least one incorporated feature includes one or more radial grooves (78’s) stretching helically (“spirally” ¶77, figure 14) along and around the circumference of the ultrasonic blade, wherein the edges of the grooves have abrasive surfaces (where the outer surface 79 and the radial groove wall meet to form an edge). Regarding claim 6, Onuma et al. disclose the blade tip includes at least one of wedge-shaped, arc-shaped, ring, cross-shaped, or circular-shaped (figure 12).
Regarding claim 7, Onuma et al. disclose the distal end is configured to have a recurve configuration the distal end (figure 8); the distal end of the blade tip being relatively thin compared to the proximal end (figure 8); and the blade tip including a smooth, flat surface (47, figure 8).
Regarding claim 8, Onuma et al. disclose the ultrasonic blade includes one or more lumens to irrigate out of the blade tip (68, figure 11, ¶66 the lumen is used to aspirate but could be used to, i.e. is capable of, irrigate by replacing suction with fluid delivery).
Regarding claim 9, Onuma et al disclose the ultrasonic vibration transmission and irrigation out of the blade tip is performed simultaneously (¶68, if one so chooses to irrigate instead of aspirate).
Regarding claim 11, Onuma et al. disclose the ultrasonic blade is readily attachable to and detachable from the transmission assembly (¶32).
Regarding claim 12, Onuma et al. disclose an ultrasonic surgical tip, comprising an ultrasonic blade (15) including a blade tip at a distal end configured to be coupled to a waveguide (28A, ¶32, ¶41), encapsulated by a transmission assembly (26), at a proximal end, wherein the waveguide is configured transmit ultrasonic vibrations from the transducer to the ultrasonic blade (¶65); and the ultrasonic blade including at least one incorporated feature (figures 3-1), at least in part, stretching between the distal end and the proximal end, wherein the at least one incorporated feature includes one or more depressions or protrusions (see figure below/65), forming abrasive surfaces (66) and channels (see figure below, the respective surface which forms the edge between the depressions and protrusions/65, 68), wherein the abrasive surfaces breakup tissue and the channels expel the broken-up tissue (¶5, ¶41-42, ¶47, ¶63, ¶66, ¶74, ¶78), wherein the at least one incorporated feature includes an offset pattern of embedded dimples (see figure below, dimples are longitudinally offset about axis “C”), wherein the edges of the dimples have abrasive surfaces (see figure below). However, Onuma et al. fails to expressly teach or disclose the offset pattern of embedded dimples extend around an outer circumference of the blade tip, the circumference being transverse to a longitudinal axis of the blade tip extending between the proximal end and the distal end, wherein the edges comprise closed circles.
Houser discloses an ultrasonic blade (600,figures 21-22) having at least one incorporated feature (650’s), wherein the at least one incorporated feature includes a plurality of offset dimples (650’s, figures 21-22 are circumferentially offset) extending around an outer circumference of the blade tip (figures 21-22), wherein edges of the at least one incorporated feature comprise closed circles (figures 21-22) and have abrasive surfaces (652, figure 22, ¶73) as it is a known alternative construct for forming a tissue cutting edge to form and shape tissue and also assist in the removal of cortical bone (¶73).
Accordingly, it would have been obvious to one of ordinary skill in the art at the time of filing to have constructed the at least one incorporated feature to include plurality of offset dimples extending around an outer circumference of the blade tip, wherein edges of the at least one incorporated feature comprise closed circles and have abrasive surfaces as taught by Houser as having closed circle dimples is a known alternative construct for forming a tissue cutting edge to form and shape tissue and also assist in the removal of cortical bone.
Regarding claim 14, Onuma et al. disclose the at least one incorporated feature includes one or more perpendicular radial grooves (78’s) stretching along and around the circumference of the ultrasonic blade, wherein the edges of the grooves have abrasive surfaces (where the outer surface 79 and the radial groove wall meet to form an edge). Regarding claim 15, Onuma et al. disclose the at least one incorporated feature includes a single, radial groove (78) stretching helically (“spirally” ¶77, figure 14) along and around the circumference of the ultrasonic blade, wherein the edges of the grooves have abrasive surfaces (where the outer surface 79 and the radial groove wall meet to form an edge). Regarding claim 17, Onuma et al. disclose the blade tip includes at least one of wedge-shaped, arc-shaped, ring, cross-shaped, or circular-shaped (figure 12). Regarding claim 18, Onuma et al. disclose the ultrasonic blade includes one or more lumens to irrigate out of the blade tip (68, figure 11, ¶66 the lumen is used to aspirate but could be used to, i.e. is capable of, irrigate by replacing suction with fluid delivery). Regarding claim 19, Onuma et al. disclose the ultrasonic vibration transmission and irrigation out of the blade tip is performed simultaneously (¶68, if one so chooses to irrigate instead of aspirate).
Regarding claim 20, Onuma et al. disclose the ultrasonic blade is readily attachable to and detachable from the transmission assembly (¶32). Regarding claim 21, Onuma et al. in view of Houser disclose the ultrasonic blade provides an irrigation fluid through the one or more lumens (¶74 of Houser). Regarding claim 22, Onuma et al. in view of Houser disclose the one or more lumens is a single axial lumen (“central lumen” ¶74), each with an irrigation inlet enabling single directional flow (¶74 of Houser).
Regarding claim 23, Onuma et al. in view of Houser disclose the ultrasonic blade provides an irrigation fluid through the one or more lumens (¶74 of Houser)
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Claims 5 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Onuma et al. (US 2016/0157884) in view of Houser (US 2008/0234709) in further view of Colyer et al. (US 2018/0193056).
Regarding claims 5 and 16, Onuma et al. in view of Houser disclose the claimed invention except for the express teaching of the at least one incorporated feature includes a first radial groove stretching helically along and around the circumference of the ultrasonic blade in a first direction; and a second radial groove stretching helically along and around the circumference of the ultrasonic blade in a second direction, wherein the first and second radial groves intersect and create crossed spiral grooves, wherein the edges of the grooves have abrasive surfaces.
Colyer et al. disclose a surgical instrument with a cutting blade (14) at a distal region (16) with at least one incorporated feature being a first radial groove (50/52) stretching helically along and around the circumference of the ultrasonic blade in a first direction (¶72-73, figure 1); and a second radial groove (54/56) stretching helically along and around the circumference of the ultrasonic blade in a second direction (¶72-73, figure 1), wherein the first and second radial groves intersect and create crossed spiral grooves (figure 1), wherein the edges of the grooves have abrasive surfaces (where outer surface 20 and the terminus of each groove meet to form an edge) as it is a known alternative configuration for providing relief channel in the cutting end of a surgical instrument. Accordingly, it would have been obvious to one of ordinary skill in the art at the time of filing to have constructed the surgical instrument of Onuma et al. to have the at least one incorporated feature includes a first radial groove stretching helically along and around the circumference of the ultrasonic blade in a first direction; and a second radial groove stretching helically along and around the circumference of the ultrasonic blade in a second direction, wherein the first and second radial groves intersect and create crossed spiral grooves, wherein the edges of the grooves have abrasive surfaces as taught by Colyer et al. as it is a known alternative configuration for providing relief channel in the cutting end of a surgical instrument.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW JAMES LAWSON whose telephone number is (571)270-7375. The examiner can normally be reached Mon - Fri 6:30-3:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anita Coupe can be reached at 571-270-3614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW J LAWSON/Primary Examiner, Art Unit 3619