Detailed Action
This is the final office action for US application number 18/280,139. Claims are evaluated as filed on May 11, 2026.
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 May 11, 2026 have been fully considered but they are not persuasive. The rejections in this office action have been amended to address the amended claims. Examiner asserts that Hafeli and Tulkis teach all the newly-amended limitations and are capable of performing the functions as claimed. Examiner directs Applicant to the rejection below for a more in-depth description of the limitations.
With regards to Applicant’s argument that Hafeli does not disclose that the quadrilateral cross-sections of the central cavities and central support member are formed by four substantially linear slides (Remarks p. 6-9), Examiner agrees and notes that such is taught by Tulkis in the below rejections.
Priority
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
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 of this title, 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.
Claim(s) 1, 2, 5, 7-13, 16, 18, and 22-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hafeli (US 5,006,121) in view of Tulkis (US 2010/0262146).
The claimed phrase “formed” is being treated as a product by process limitation; that is the product reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113.
As to claims 1, 2, 5, 7-10, 12, 16, 18, 22-25, Hafeli discloses a surgical tool (Figs. 1-7, col. 4 lines 25-37) capable of preparing a bone canal (abstract), the surgical tool comprising: at least one cutting unit (26, 28, Fig. 1) capable of removing or compacting bone tissues (Fig. 1, abstract), wherein said cutting unit comprises a plurality of autonomous cutting members (“individual broach plates” of col. 2 line 65 and shown individually in Figs. 6 and 7, Figs. 1 and 3-7, col. 4 lines 25-37), wherein each of the plurality of autonomous cutting members is disposed in contact with an adjacent one of the plurality of autonomous cutting members (Fig. 1) according to a determinate sequence along a common longitudinal axis (vertical axis along 30 as shown in Fig. 2, Figs. 1 and 2, col. 2 line 55 – col. 3 line 5, col. 3 lines 27-32 and 60-65, col. 4 lines 4-14 and 25-37), wherein each of said cutting members comprises a central cavity (50, 38, Fig. 7, col. 3 lines 25 and 27-32, col. 4 lines 25-37) substantially coaxial to said longitudinal axis (as defined, Figs. 1-3 and 7), wherein the central cavities of said cutting members collectively define a central channel (channel that receives 30 and 52, Figs. 1-3 and 7, col. 3 lines 25 and 27-32, col. 4 lines 25-37), wherein the central cavity of each cutting member is complementary in shape with the adjacent cutting member along the longitudinal axis (Figs. 1-3 and 7, col. 3 lines 25 and 27-32, col. 4 lines 25-37) in order to give the central channel a desired shape (Fig. 1, co1. 4 lines 4-14), the central channel comprising a first tapered portion (Figs. 1, 6, and 7, col. 3 lines 23 and 27-32) and a second rectilinear portion (50, Fig. 7, col. 4 lines 28-29), wherein said surgical tool further comprises a central support member (32) disposed inside said central channel (Figs. 1-3 and 7, col. 3 lines 25 and 27-32, col. 4 lines 25-37) and capable of giving structural rigidity to said cutting unit (Fig. 1, col. 3 lines 61-66), wherein each cutting member comprises a metal plate (Figs. 6 and 7, col. 1 lines 49-50) of a determinate thickness (Fig. 6, col. 4 lines 4-10) and has lateral walls inclined in a direction of the thickness by an angle α with respect to the longitudinal axis (Fig. 6, col. 3 lines 51-60), wherein said angle α is variable depending on a considered side of the cutting member (Fig. 1, col. 3 lines 51-60, col. 4 lines 4-10 and 43-48), wherein said angle α is between about 10° and about 40° (Fig. 6, col. 3 lines 51-60), wherein a cross-section of the central cavities and a cross-section of the central support member are quadrilateral (see illustration of Fig. 7, Fig. 7) capable of preventing rotation of the cutting members around the longitudinal axis (col. 4 lines 28-32). As to claim 2, Hafeli discloses a first element (24) associated with said cutting unit (Fig. 1) and capable of being mechanically connected to an external tool holder (Fig. 1). As to claim 5, Hafeli discloses that the cutting unit as a whole is oblong in shape and is substantially tapered along a longitudinal axis thereof from a first end to a second end (Figs. 1, 6, and 7). As to claim 7, Hafeli discloses a first element (24), wherein said first element is connected to a first end of said central support member (Figs. 1 and 2), wherein a second element (22) is connected to a second end of said central support member opposite said first end (Figs. 1 and 2, col. 3 lines 61-66). As to claim 8, Hafeli discloses that said second element is made in a single body with said central support member (Fig. 2). As to claim 9, Hafeli discloses that said first element comprises a connector (upper portion as shown in Fig. 2, Figs. 1 and 2) capable of being connected to an external tool holder (Figs. 1 and 2). As to claim 10, Hafeli discloses that the cutting member at a first end of the cutting unit is mechanically connected by welding or gluing to the first element (col. 5 lines 10-13). As to claim 12, Hafeli discloses that said second element in cooperation with the first element prevents the cutting unit from sliding out of the central support member (Figs. 1, 2, and 7, col. 3 lines 61-66). As to claim 16, Hafeli discloses that said central support member is complementary in shape with the central channel (Fig. 7), said central support member comprising a first tapered portion (Fig. 7) and a second rectilinear portion (52). As to claim 18, Hafeli discloses that each of said cutting members is connected mechanically or by welding with another adjacent one of said cutting members (Fig. 1 or col. 5 lines 10-12). As to claim 22, Hafeli discloses that the cutting members have a quadrilateral shape (Fig. 7), or an elliptical, polygonal, or round shape (Fig. 7). As to claim 23, Hafeli discloses that each cutting member has a determinate height (Figs. 1 and 7) and a determinate width (Figs. 1 and 7), wherein the cutting members have a different height and width from each other (Figs. 1 and 7) and the sequence in which they are disposed along the longitudinal axis is such as to give the cutting unit a desired tapered profile (Fig. 1). As to claim 24, Hafeli discloses that each of the cutting members also comprises at least one cutting element (Figs. 1 and 7, col. 3 lines 17-18 and 51-60, col. 4 lines 4-10 and 43-48). As to claim 25, Hafeli discloses that the cutting elements of each cutting member comprise one or more lateral edges (Figs. 1 and 7, col. 3 lines 17-18 and 51-60, col. 4 lines 4-10 and 43-48).
Hafeli is silent the quadrilateral cross-sections of the central cavities and the central support member are formed by four substantially linear sides.
Tulkis teaches a similar surgical tool (Figs. 6-7D, abstract) capable of preparing a bone canal (abstract), the surgical tool comprising: at least one cutting unit (60s, Figs. 7A-7D) capable of removing or compacting bone tissues (Figs. 6-7D, abstract), wherein said cutting unit comprises a plurality of autonomous cutting members (60s, Figs. 7A-7D, ¶27), wherein each of the plurality of autonomous cutting members is disposed in contact with an adjacent one of the plurality of autonomous cutting members (Fig. 7C) along a common longitudinal axis (Figs. 7A-7D), wherein each of said cutting members comprises a central cavity (Figs. 7A-7D) substantially coaxial to said longitudinal axis (as defined, Figs. 7A-7D), wherein the central cavities of said cutting members collectively define a central channel (Figs. 7A-7D), wherein the central cavity of each cutting member is complementary in shape with the adjacent cutting member along the longitudinal axis (Figs. 7A-7D) in order to give the central channel a desired shape (Figs. 7A-7D), wherein said surgical tool further comprises a central support member (20, Fig. 2, ¶27 discloses that such is like the reamer 10) disposed inside said central channel (Figs. 1-2, ¶27 discloses that such is like the reamer 10), wherein a cross-section of the central cavities and a cross-section of the central support member are quadrilateral (Figs. 7A-7D, abstract), formed by four substantially linear sides (Figs. 7A-7D), capable of preventing rotation of the cutting members around the longitudinal axis (Figs. 7A-7D, abstract).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the quadrilateral cross-sections of the central cavities and the central support member as disclosed by Hafeli to be formed by four substantially linear sides as taught by Tulkis in order to provide a known alternate shape (Tulkis Figs. 2, 4, and 7A-7D) for rotationally coupling the plates to the central support member (Tulkis abstract) using mating flattened areas on the internal surface of the plates and the external surface of the central support member (Tulkis abstract).
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As to claims 27-29, Hafeli discloses a method (Figs. 1-7, col. 4 lines 14-42) capable of producing a surgical tool (Figs. 1-7, col. 4 lines 25-37), the method comprising: - providing a plurality of cutting members (“individual broach plates” of col. 2 line 65 and shown individually in Figs. 6 and 7, Figs. 1 and 3-7, col. 4 lines 25-37), wherein each cutting member of the plurality of cutting members is distinct and separate from other cutting members of the plurality of cutting members (shown individually in Figs. 6 and 7, Figs. 1 and 3-7, col. 4 lines 25-37); and - disposing each of said cutting members in contact with an adjacent cutting member (Fig. 1) according to a determinate sequence along a longitudinal axis (vertical axis along 30 as shown in Fig. 2, Figs. 1 and 2, col. 2 line 55 – col. 3 line 5, col. 3 lines 27-32 and 60-65, col. 4 lines 4-14 and 25-37) in order to make up a cutting unit (26, 28, Fig. 1), wherein each of said cutting members comprises a central cavity (50, 38, Fig. 7, col. 3 lines 25 and 27-32, col. 4 lines 25-37) substantially coaxial to said longitudinal axis (as defined, Figs. 1-3 and 7), wherein the central cavities of said cutting members collectively define a central channel (channel that receives 30 and 52, Figs. 1-3 and 7, col. 3 lines 25 and 27-32, col. 4 lines 25-37), wherein the central cavity of each cutting member is complementary in shape with the adjacent cutting member along the longitudinal axis (Figs. 1-3 and 7, col. 3 lines 25 and 27-32, col. 4 lines 25-37) in order to give the central channel a desired shape (Fig. 1, co1. 4 lines 4-14), the central channel comprising a first tapered portion (Figs. 1, 6, and 7, col. 3 lines 23 and 27-32) and a second rectilinear portion (50, Fig. 7, col. 4 lines 28-29), wherein said surgical tool further comprises a central support member (32) disposed inside said central channel (Figs. 1-3 and 7, col. 3 lines 25 and 27-32, col. 4 lines 25-37) and capable of giving structural rigidity to said cutting unit (Fig. 1, col. 3 lines 61-66), wherein each cutting member comprises a metal plate (Figs. 6 and 7, col. 1 lines 49-50) of a determinate thickness (Fig. 6, col. 4 lines 4-10) and has lateral walls inclined in a direction of the thickness by an angle α with respect to the longitudinal axis (Fig. 6, col. 3 lines 51-60), wherein said angle α is variable depending on a considered side of the cutting member (Fig. 1, col. 3 lines 51-60, col. 4 lines 4-10 and 43-48), wherein said angle α is between about 10° and about 40° (Fig. 6, col. 3 lines 51-60), wherein a cross-section of the central cavities and a cross-section of the central support member are quadrilateral (see illustration of Fig. 7, Fig. 7) capable of preventing rotation of the cutting members around the longitudinal axis (col. 4 lines 28-32). As to claim 28, Hafeli discloses - producing, or having available, said central support member complementary in shape with said central channel (Figs. 1-3 and 7, col. 3 lines 25 and 27-32, col. 4 lines 25-37); and - inserting each of said cutting members on said central support member in accordance with said determinate sequence (Fig. 1, col. 3 lines 61-66). As to claim 29, Hafeli discloses making said cutting members by one of the following processes: laser cutting, milling, or additive manufacturing (col. 4 lines 15-42).
Hafeli is silent the quadrilateral cross-sections of the central cavities and the central support member are formed by four substantially linear sides.
Tulkis teaches a similar method (Figs. 6-7D, abstract) capable of producing a surgical tool (Figs. 6-7D, abstract), the method comprising: - providing a plurality of cutting members (60s, Figs. 7A-7D), wherein each cutting member of the plurality of cutting members is distinct and separate from other cutting members of the plurality of cutting members (Figs. 7A-7D, ¶27); and - disposing each of said cutting members in contact with an adjacent cutting member (Fig. 7C) along a longitudinal axis (Figs. 7A-7D ) in order to make up a cutting unit (Figs. 7A-7D), wherein each of said cutting members comprises a central cavity (Figs. 7A-7D) substantially coaxial to said longitudinal axis (as defined, Figs. 7A-7D), wherein the central cavities of said cutting members collectively define a central channel (Figs. 7A-7D), wherein the central cavity of each cutting member is complementary in shape with the adjacent cutting member along the longitudinal axis (Figs. 7A-7D) in order to give the central channel a desired shape (Figs. 7A-7D), wherein said surgical tool further comprises a central support member (20, Fig. 2, ¶27 discloses that such is like the reamer 10) disposed inside said central channel (Figs. 1-2, ¶27 discloses that such is like the reamer 10), wherein a cross-section of the central cavities and a cross-section of the central support member are quadrilateral (Figs. 7A-7D, abstract), formed by four substantially linear sides (Figs. 7A-7D), capable of preventing rotation of the cutting members around the longitudinal axis (Figs. 7A-7D, abstract).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the quadrilateral cross-sections of the central cavities and the central support member as disclosed by Hafeli to be formed by four substantially linear sides as taught by Tulkis in order to provide a known alternate shape (Tulkis Figs. 2, 4, and 7A-7D) for rotationally coupling the plates to the central support member (Tulkis abstract) using mating flattened areas on the internal surface of the plates and the external surface of the central support member (Tulkis abstract).
As to claim 10, the combination of Hafeli and Tulkis discloses the invention of claim 7 and appears to disclose that the cutting member at a first end of the cutting unit is mechanically connected by welding or gluing to the first element (col. 5 lines 10-13), but does not explicitly state that the cutting member at a first end of the cutting unit is mechanically connected by welding or gluing to the first element.
Hafeli teaches that if desired broach plates may be cemented to each other, whether a curved or straight mandrel is used, to prevent any possible shifting of the broach plates with respect to each other and that broaches may be fabricated in accordance with the present invention by cementing the broach plates to each other to form a rigid stack (col. 5 lines 10-20).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to specify that the cutting member at a first end of the cutting unit and the first element as disclosed by the combination of Hafeli and Tulkis are mechanically connected by welding or gluing as taught by Hafeli in order to prevent any possible shifting of the cutting member at the first end of the cutting unit (Hafeli col. 5 lines 10-13).
As to claim 11, the combination of Hafeli and Tulkis discloses the invention of claim 7 as well as the first element is disposed at the first end of said central support member (as defined, Figs. 1 and 2). Hafeli further discloses that once the individual cutting members have been completed by the formation of the final cutting edge, they are stacked in proper order on the central support member, the assembly being clamped in position by rotating the second element to thread the first end of the central support member into the first element (col. 3 lines 61-66).
The combination of Hafeli and Tulkis is silent to the first element is made in a single body with said central support member.
That is, the combination of Hafeli and Tulkis discloses the claimed invention except for the first element being threadedly connected to the central support member with the second element made in a single body with said central support member to clamp the assembly of cutting members. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the second element being threadedly connected to the central support member with the first element made in a single body with said central support member, since rearranging parts of an invention involves only routine skill in the art and provides a known clamping of the cutting members (Hafeli col. 3 lines 61-66). In other words, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to construct the second element and the central support member as separate connectable structure, since constructing a formerly integral structure in various elements involves only routine skill in the art and provides a known clamping of the cutting members (Hafeli col. 3 lines 61-66). Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to specify that the first element and said central support member are formed as a single unit, since forming in one piece an article which has formerly been constructed as an integral structure involves only routine skill in the art and provides a known clamping of the cutting members (Hafeli col. 3 lines 61-66).
As to claim 13, the combination of Hafeli and Tulkis discloses the invention of claim 7 as well as the first end of the central support member comprises a coupling portion (Fig. 2, col. 2 line 67 – col. 3 line 2, col. 3 lines 64-66) capable of being mechanically and reversibly connected to the first element (Fig. 2, col. 2 line 67 – col. 3 line 2, col. 3 lines 64-66) capable of allowing disconnection of the first element from the central support member for replacing the cutting unit (Figs. 1 and 2, col. 2 line 67 – col. 3 line 2, col. 3 lines 64-66). That is, Hafeli discloses that once the individual cutting members have been completed by the formation of the final cutting edge, they are stacked in proper order on the central support member, the assembly being clamped in position by rotating the second element to thread the first end of the central support member into the first element (col. 3 lines 61-66).
The combination of Hafeli and Tulkis is silent to the second end of the central support member comprises a coupling portion configured to be mechanically and reversibly connected to the second element to allow disconnection of the second element from the central support member for replacing the cutting unit.
That is, the combination of Hafeli and Tulkis discloses the claimed invention except for the first element being threadedly connected to the central support member with the second element made in a single body with said central support member to clamp the assembly of cutting members. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the second element being threadedly connected to the central support member with the first element made in a single body with said central support member, since rearranging parts of an invention involves only routine skill in the art and provides a known clamping of the cutting members (Hafeli col. 3 lines 61-66). Alternately, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to construct the second element and the central support member as a threadedly connectable separate structure, since constructing a formerly integral structure in various elements involves only routine skill in the art and provides a known clamping of the cutting members (Hafeli col. 3 lines 61-66).
As to claim 26, the combination of Hafeli and Tulkis discloses the invention of claim 24.
The combination of Hafeli and Tulkis is silent a plurality of protrusions made on lateral walls of each cutting member, or, alternatively, in correspondence with a lateral edge.
Hafeli, in an alternate embodiment, teaches a similar tool (Figs. 1-6 and 8, col. 4 lines 50-62) comprising cutting members (Fig. 8) comprising at least one cutting element (Fig. 8) such that the cutting elements comprise a plurality of protrusions (Fig. 8) made on lateral walls of each cutting member (Fig. 8, col. 4 lines 50-62), or, alternatively, in correspondence with a lateral edge (Fig. 8, col. 4 lines 50-62).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the cutting elements as disclosed by the combination of Hafeli and Tulkis to have protrusions as taught by Hafeli, in an alternate embodiment, in order to reduce the total length of active cutting edge to reduce the force required to insert the broach (Hafeli col. 4 lines 45-52) and enable protrusion position to be staggered between cutting members so that the cutting element of two or more cutting members is combined to define the desired bone opening for the corresponding axial position or positions of the cutting members on the tool assembly (Hafeli col. 4 lines 53-57).
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY SIPP whose telephone number is (313)446-6553. The examiner can normally be reached on Monday through Thursday, 6:30am-4pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong can be reached on 571-272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMY R SIPP/Primary Examiner, Art Unit 3775
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