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 Amendment
This Office action is responsive to the amendment filed 10/09/2025. Claims 1, 3, 4, 6, 13-14 and 17 have been amended. Claim 2 has been cancelled. Claims 1 and 3-20 are currently pending in the application.
Response to Arguments
Applicant’s arguments, see pg. 7, filed 10/09/2025, with respect to the objection to the specification have been fully considered and are persuasive. The objections to the specification has been withdrawn.
Applicant’s arguments, see pg. 7, with respect to the objections to the claims have been fully considered and are persuasive. The objections to the claims have been withdrawn.
Applicant’s arguments, see pg. 7, with respect to the rejections of the claims under 35 U.S.C. 112(b) have been fully considered and are persuasive. The rejections under 35 U.S.C. 112(b) have been withdrawn.
Applicant's arguments, see pg. 8-12, with respect to the rejections of the claims under 35 U.S.C. 102 and 103 have been fully considered but they are not persuasive.
Applicant argues that the combination of Detsch and Eriksson would not teach the surgical cutting device of claim 1 because Eriksson does not disclose spacers which define a penetration depth of the cutting edge into the body. However, Applicant has not made clear in the arguments why the screws 66 of Eriksson are not spacers (see Fig. 7 and [0029] of Eriksson).
The Examiner maintains that the screws 66 of Eriksson can be considered spacers since they define the penetration depth of the blade 18 as expressly stated in the reference (“When screws 66 are rotatably inserted into apertures 74, the inner surfaces 76 of screw heads 70 define a depth relative to end wall 28 that, in turn, defines the depth of cutting edge 44”, see [0029]).
It is noted that the amendments to claim 1 overcomes the rejection of the claim under 35 U.S.C. 102(a)(1) as being anticipated by Detsch (US 4,221,222). Therefore, the rejection has been withdrawn.
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, 6-7, 11-17, 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Eriksson et al. (US 2004/0225309) in view of Detsch.
Regarding claims 1 and 12, Eriksson discloses a surgical cutting device (10, see Fig. 1-5) in otology for the production of a thin tissue or cartilage slice from a patient's own body material for otological applications (the device of Eriksson is a medical cutting instrument so it can be used to harvest tissue for ontological applications, see [0005]), comprising: an elongate device body (12) which is aligned along a longitudinal axis, and which comprises at a first end a handle-like grip (14) and at an opposite second end a cutting head (16) with a cutting blade (18) having a blade body with a sharp cutting edge (44), wherein the cutting blade is arranged within a cutting window (34) which is continuously open in a direction transverse to a direction of the longitudinal axis; and wherein the cutting blade is connected to the device body either rigidly or movably about the transverse axis (blade 18 is rigidly connected to the device body when the screws 66 are tightened and movable when they are loose, see [0030]), wherein the cutting window (34, see Fig. 5) and the cutting blade (18) are accommodated in a cutting body (20) which is rigidly connected to the device body (see Fig. 3), and wherein the cutting body has a spacer (66, see Fig. 7) which defines a penetration depth of the sharp cutting edge into the patient's own body material and thus a thickness of a thin tissue or cartilage slice which is peeled out (screws 66 set the penetration depth of the blade, see [0029]), wherein the spacer is adjustable (screws 66 can be adjusted by their head portions 70 which form discs, see Fig. 7 and 9).
Eriksson fails to teach wherein the cutting blade is positioned in the cutting window in such a manner that the sharp cutting edge is aligned parallel to a transverse axis, which extends perpendicular to the longitudinal axis and obliquely to the direction, wherein the sharp cutting edge of the cutting blade is positioned axially away from the blade body in a direction of the longitudinal axis towards the handle-like grip and the handle-like grip has a hollow or concave structure.
It is noted that these claim limitations refer to the orientation of the cutting edge relative to the handle and Eriksson contemplates that the position of handle can be changed in order to accommodate the grip preferences of different users (see [0020]). Eriksson simply does not teach the specific blade-handle arrangement claimed.
Detsch, in the same field of art, teaches a related surgical cutting device (see Fig. 1-4) comprising a handle-like grip (14), a cutting blade (28) having a cutting edge (32), wherein the cutting blade is arranged within a cutting window (26), wherein the cutting blade is positioned in the cutting window in such a manner that the sharp cutting edge is aligned parallel to a transverse axis, which extends perpendicular to the longitudinal axis and obliquely to the direction (the sharp portion 32 is aligned parallel to an axis extending into and out of the page in annotated Fig. 4 above which is perpendicular to the longitudinal axis z and oblique to the direction x’) and wherein the sharp cutting edge of the cutting blade is positioned axially away from the blade body in the direction of the longitudinal axis towards the handle-like grip (see Fig. 4), and the handle-like grip has a concave structure (portion 16 of the handle has a concave structure, see Fig. 3).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to substitute the blade-handle arrangement of Eriksson with the blade-handle arrangement of Detsch since doing so would have yielded only predictable results, namely, the handle arrangement of Detsch in the device of Eriksson would have allowed a user an alternative grip for harvesting tissue. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding claim 3, the combination of Eriksson and Destch teaches the cutting device according to claim 1. Eriksson further discloses wherein the spacer is adjustable via one or more spacer discs (screws 66 can be adjusted by their head portions 70 which form discs, see Fig. 7 and 9).
Regarding claim 6, the combination of Eriksson and Destch teaches the cutting device according to claim 1. Eriksson further discloses wherein the cutting blade is arranged in the cutting body with a side of the sharp cutting edge tilted by a setting angle of between 10° and 40° relative to a z-y plane (the blade 18 is positioned at an angle relative to a z-y plane formed by base 30 within the range of 15°-30°, which is within the claimed range, see [0021] and Fig. 5).
Regarding claim 7, the combination of Eriksson and Destch teaches the cutting device according to claim 1. Eriksson further discloses wherein the cutting blade is produced from a razor blade (blade 18 is considered a razor blade since it is a thin blade, see Fig. 3-4).
Regarding claim 11, the combination of Eriksson and Destch teaches the cutting device according to claim 1. Eriksson further discloses wherein parts of the cutting device are made of plastic (the handle can be made of plastic, see [0018]).
Regarding claims 13 and 20, the combination of Eriksson and Destch teaches the cutting device according to claim 1. Eriksson further discloses wherein the sharp cutting edge of the cutting blade has a beam-like or a sawtooth-like or a sickle-like or an oval or a round, concave or convex shape on a circular portion, wherein the circular portion is in the form of a quarter circle or semicircle (while shown having a straight cutting edge 44, blade 18 can instead have a scalloped cutting edge which would be understood to have portions forming a semi-circular concave shape, see [0024]).
Regarding claim 14, Eriksson further teaches a method wherein the sharp cutting edge of the cutting device is placed on a suitable part of the patient's body with slight pressure, and wherein a desired tissue or cartilage slice is peeled out of the patient's own body material by pulling the cutting device in the direction of the grip (see Fig. 10 and [0032]-[0033]).
Regarding claims 15 and 16, the combination of Eriksson and Destch teaches the cutting device according to claim 3, but fails to expressly teach wherein the spacer discs (head portions 70 of screws 66, see Fig. 7 of Eriksson) have a thickness between 0.3 mm and 0.4 mm.
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 device of Eriksson and Destch so that the spacer discs have a thickness between 0.3 mm and 0.4 mm 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 Eriksson and Destch would not operate differently with the claimed thickness and since the thickness of the head portion 70 of the screws 66 in Eriksson does not impact their ability to control the depth of the blade, the device would function appropriately having the claimed thickness. Further, Applicant places no criticality on the range claimed, indicating simply that the thickness is “preferably” within the claimed range (see Specification pp. [0033]).
Regarding claim 17, the combination of Eriksson and Destch teaches the cutting device according to claim 1. Eriksson further discloses wherein the cutting blade is arranged in the cutting body with a side of the sharp cutting edge tilted by a setting angle of approximately 25° relative to a z-y plane (the angle formed between blade 18 and the z-y plane formed by base 30 can be 25° since Eriksson discloses the angle can be within the range of 15°-30°, see [0021] and Fig. 5).
Regarding claim 19, the combination of Eriksson and Destch teaches the cutting device according to claim 11. Eirksson further teaches wherein the handle-like grip is made of plastic (see [0018]).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Eriksson and Detsch, as applied to claim 1 above, and further in view of Gilhaus et al. (US 3,797,505).
Regarding claim 4, the combination of Eriksson and Destch teaches the cutting device according to claim 1, but fails to teach wherein the cutting head has a viewing window following the cutting body, wherein the viewing window is axially offset in the direction of the longitudinal axis towards the handle-like grip and which is continuous in the direction of a vertical axis perpendicular to the longitudinal axis and perpendicular to the transverse axis.
Gilhaus, in the same field of art, teaches a related cutting device having a viewing window (24, see Fig. 5) axially offset in the direction of the longitudinal axis towards the handle-like grip (the window 24 is axially offset from the axis the longitudinal axis z as shown in annotated Fig. 6 below) and which is continuous in the direction of a vertical axis (window 24 is continuous in the direction of the vertical axis x, see annotated Fig. 6 ) perpendicular to the longitudinal axis and perpendicular to the transverse axis (the vertical axis is perpendicular to the longitudinal axis z and a transverse axis z going into and out of the page in annotated Fig. 6). This arrangement allows for better viewing of the operation area (see col. 5, lines 6-16).
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It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the cutting device of Eriksson and Detsch so that it includes a viewing window, as taught by Gilhaus, since doing so would enhance the operators view of the operation area.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Eriksson and Detsch, as applied to claim 1 above, further in view of Bradica et al. (US 2006/0173476), and further in view Eifler (US 2,309,177).
Regarding claim 5, the combination of Eriksson and Destch teaches the cutting device according to claim 1, but fails to teach a cartilage punching device is arranged at a free end of the handle-like grip opposite the cutting head.
Bradica, in the same field of art, teaches a cartilage punching device (24, see Fig. 1-2) arranged at a free end (12) of a handle (16).
Bradica fails to teach the cartilage punch at the opposite end of a cutting head. However, combination cutting tools with different cutters arranged at opposite ends of a handle are well known.
Eifler teaches a combination tool (10, see Fig. 1) with different cutters (blades 15 and 16) arranged at opposite ends of a handle (14). This arrangement increases the versatility and efficiency of the tool as well as minimizes manufacturing costs (see col. 1, lines 12-16).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the cutting device of Eriksson and Detsch so that it includes the cartilage punching device taught by Bradica arranged at the opposite end of the handle from the cutting head, since all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods, as evidenced by Eifler, with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art, i.e., one skilled in the art would have recognized that combining the cartilage punching device of Bradica with the cutting device of Eriksson and Detsch would have provided the device with more versatility with respect to the kinds of tissue harvesting operations that can be performed using the device, particularly since the cutting device of Eriksson and Detsch and the cartilage punching device of Bradica are used to harvest patient tissue. KSR, 550 U.S. at 416, 82 USPQ2d at 1395.
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Eriksson and Detsch, as applied to claims 1 and 7 above, and further in view of Wortrich (US 2002/0143351).
Regarding claims 8 and 9, the combination of Eriksson and Detsch teaches the cutting device according to claims 1 and 7, but fails to expressly teach the cutting blade is produced from stainless steel and wherein the sharp cutting edge of the cutting blade has a bevelled polished section on both sides.
Wortrich, in the same field of art, teaches a cutting blade (see Fig. 1 and 4) produced from stainless steel and wherein the sharp cutting edge of the cutting blade has a bevelled polished section on both sides (see [0012]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the cutting blade of Eriksson and Detsch to specifically be made of stainless steel, as taught by Wortrich, since stainless steel was known as an acceptable material from which to make a surgical cutting blade and since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
It further would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the cutting blade of Eriksson and Detsch so that the cutting edge has a beveled polish on both sides, as taught by Wortrich, since doing so would enhance the sharpness of the blade.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Eriksson and Detsch, as applied to claim 1 above, and further in view of Lucas et al. (US 2009/0138027).
Regarding claim 10, the combination of Eriksson and Destch teaches the cutting device according to claim 1, but fails to expressly teach wherein the entire device body of the cutting device is made of stainless steel.
Lucas, in the same field of art, teaches a surgical cutting device (22) having a device body (74, see Fig. 1) made of stainless steel (see [0030]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the device body of Eriksson and Detsch to specifically be made of stainless steel, as taught by Lucas, since stainless steel was known as an acceptable material from which to make a surgical cutting device and since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Eriksson, Detsch, and Wortrich, as applied to claim 9 above, and further in view of Mirza et al. (US 2017/0042566).
Regarding claim 18, the combination of Eriksson, Detsch, and Wortrich teaches the cutting device according to claim 9, but fails to expressly teach wherein the sharp cutting edge is hardened.
Mirza, in the same field of art, teaches a cutting blade made of hardened stainless steel (see [0081]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the cutting blade of Eriksson, Detsch, and Wortrich to specifically be made of hardened stainless steel, as taught by Mirza, since hardened stainless steel was known as an acceptable material from which to make a surgical cutting blade and since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 SERENITY MILLER whose telephone number is (571)272-1155. The examiner can normally be reached Monday-Friday 8:00am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at (571)272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SERENITY A MILLER/Examiner, Art Unit 3771
/KATHERINE M SHI/Primary Examiner, Art Unit 3771