Detailed Action
This is the final office action for US application number 18/658,145. 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, 2026have 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 Callahan and Mikhail 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With regards to Applicant’s claims 5, 10, 12, and 15-20 are withdrawn as drawn to a non-elected species (Remarks p. 7) as well as the status of claim 6, Examiner notes that claim 6 was withdrawn along with claims 5, 10, 12, and 15-20, see #4 and 5 on page 3 of the non-final office action dated February 11, 2026.
With regards to Applicant’s argument that Examiner asserts that Mikhail discloses an opening is formed between the one or more cutting features, the distal end portion, and the stop (Remarks p. 8-9), Examiner notes that this is incorrect. The argued opening was previously in claims 3 and 13. As provided on pages 6-8 of the non-final office action dated February 11, 2026, neither claim 3 nor claim 13 was rejected based upon the disclosure of Mikhail. Thus, this argument is moot.
With regards to Applicant’s argument that the blades of Mikhail perform multi-revolution reaming and has a blade geometry which is inconsistent with single-revolution cutting (Remarks p. 10), Examiner notes that there appears to be no structure or blade geometry that prevents the apparatus from performing a single revolution or from cutting when only a single revolution is performed; thus, such appears to be capable of cutting, i.e. arranged and configured to remove a discrete bone segment in a single revolution. Examiner suggests identification of feature of the ‘blade geometry’ that Applicant is asserting is capable of different functionality and amending to claim said feature.
With regards to Applicant’s argument that the claimed plunging cutting followed by at most a single rotation is structurally and functionally distinct from Mikhail (Remarks p. 10), Examiner notes that plunging cutting has not been claimed nor have any methods been recited or elected. Further, Examiner request identification of how such is purported to be structurally and functionally distinct and suggests amending to claim that feature. Further, Examiner notes that Applicant’s paragraphs 15, 22, 26, and 31 does disclose that examples 7, 14, 18, and 23 are so configured and paragraph 61 discloses that, in Figs. 3B and 3C, the nose 130 comprises sharps for plunging insertion into the bone; however, such is not shown. Instead, Fig. 1 shows the one or more cutting feature 122 being inserted into 110, where paragraph 56 discloses that “The process can include preparing the bone such as by resection of a proximal end of the bone 104 and by cutting one or more apertures 110 in a surface 112 of the metaphysis 106 prior to the insertion of the reamer 100 shown in FIGS. 1 and 2”. Thus, it appears that Applicant intends for the structure to be capable of functioning differently than such is disclosed to operate in Fig. 1 and ¶56.
With regards to Applicant’s argument that Callahan does not disclose that the blades extend from a distal nose portion to a stop as the rim 102 is part of the reamer head and is not a depth-limiting stop nor setting a desired depth for the cutting features (Remarks p. 10-11), Examiner notes that this has not been asserted; thus, this argument is moot.
With regards to Applicant’s argument that Callahan fails to teach depth control as well as being configured for plunging insertion (Remarks p. 11), Examiner notes that Callahan has not been applied as teaching anything and it has not been asserted that Callahan discloses either of these features; thus, this argument is moot.
With regards to Applicant’s argument that Callahan fails to teach a cutting feature designed to cut bone with a single revolution or less as Callahan discloses toggling the cutting features and rotating with a power drill to cut (Remarks p. 11-12), Examiner notes that the disclosed toggling of the cutting features is done during insertion of the apparatus into the joint space such that the apparatus is in the orientation shown in Fig. 2 prior to cutting (col. 4 lines 3-30). There appears to be no structure or feature disclosed by Callahan that prevents the apparatus from performing a single revolution or from cutting when only a single revolution is performed; thus, such appears to be capable of cutting, i.e. arranged and configured to remove a discrete bone segment in a single revolution. Examiner suggests identification of feature that Applicant is asserting is capable of different functionality and amending to claim said feature.
With regards to Applicant’s argument that Callahan’s reamer is specifically configured to abut the glenoid face prior to cutting (Remarks p. 11), Examiner agrees and notes that in order to cut into something, a structure must first abut or contact that something.
With regards to Applicant’s argument that Callahan does not describe an initial cut being made by axial insertion (Remarks p. 12), Examiner agrees and notes that it has not been asserted otherwise. Further, a method step of creating an initial cut being made by axial insertion has not been provided nor has Applicant disclosed using the claimed apparatus to create such a cut as detailed above.
With regards to Applicant’s argument that the claimed plunging cutting followed by at most a single rotation is structurally and functionally distinct from Callahan (Remarks p. 12), Examiner notes that it has not been asserted that Callahan discloses plunging cutting and plunging cutting has not been claimed nor have any methods been recited or elected. Further, Examiner request identification of how such is purported to be structurally and functionally distinct and suggests amending to claim that feature. Further, Examiner notes that Applicant’s paragraphs 15, 22, 26, and 31 does disclose that examples 7, 14, 18, and 23 are so configured and paragraph 61 discloses that, in Figs. 3B and 3C, the nose 130 comprises sharps for plunging insertion into the bone; however, such is not shown. Instead, Fig. 1 shows the one or more cutting feature 122 being inserted into 110, where paragraph 56 discloses that “The process can include preparing the bone such as by resection of a proximal end of the bone 104 and by cutting one or more apertures 110 in a surface 112 of the metaphysis 106 prior to the insertion of the reamer 100 shown in FIGS. 1 and 2”. Thus, it appears that Applicant intends for the structure to be capable of functioning differently than such is disclosed to operate in Fig. 1 and ¶56.
With regards to Applicant’s argument that the combination of Callahan and Mikhail different manner than the claimed apparatus with high speed reaming of small bone chips that are expelled through small apertures/flutes as the claimed opening 136 is one structural feature that facilitates single rotation reaming with the cutting features configured to cut the bone with plunging insertion, which is a different mechanical operation than the prior art that facilitates removal of larger bone segments (Remarks p. 12-13), Examiner notes that the operation, i.e. a method, is not claimed and the argued opening is only in claim 1. Further, the assertion that combination would only remove small bone fragments appears inconsistent with the combination of Callahan and Mikhail as detailed below. In summary, Callahan discloses the argued opening as shown in Fig. 2 and Mikhail teaches the stop and cutting edges of the cutting features.
Claim Objections
Claim(s) 6 is/are objected to because of the following informalities:
Claim 6 line 1 should read “(Withdrawn) The apparatus of claim 1,”.
Appropriate correction is required.
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, 4, 8, 11, 13, 21, and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Callahan et al. (US 11,123,086, hereinafter “Callahan”) in view of Mikhail (US 5,489,310).
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, 4, 8, and 21, Callahan discloses an apparatus (100, Figs. 1-3) capable of removing a desired amount of bone during an orthopedic procedure (col. 2 lines 57-60), the apparatus comprising: a shaft (116, 104, Fig. 2) having a centerline axis (horizontal and along the center of 116 as shown in Fig. 2, Fig. 2) and at least partially cannulated (118, Figs. 1 and 2, col. 3 line 47) at a distal end portion (Fig. 2); a stop (102) coupled to the shaft at or adjacent the distal end portion (Figs. 1 and 2), the stop capable of contacting a surface of the bone (if a such is so positioned, e.g. between 109a and 109d); and one or more cutting features (109a) coupled to the distal end portion and coupled to the stop (Figs. 1 and 2), wherein the one or more cutting features are capable of cutting the bone with rotation of the one or more cutting features about the centerline axis of the shaft (col. 3 lines 10-15 and 50-53), wherein an opening (Fig. 2) is formed between the one or more cutting features, the distal end portion, and the stop (Fig. 2), wherein the apparatus is inserted along an insertion axis (horizontal as shown in Fig. 2, Fig. 2). As to claim 2, Callahan discloses that the one or more cutting features comprise a single cutting feature (as defined, i.e.109a, Figs. 1 and 2). As to claim 4, Callahan discloses that each of the one or more cutting features has an arcuate profile (Fig. 2) along an outer distal surface thereof (Fig. 2). As to claim 21, Callahan discloses that wherein the one or more cutting features are constructed and arranged such that a single revolution of the shaft about the centerline axis removes a discrete bone segment that passes into the opening (due to the shown structure, Fig. 2).
Callahan is silent to the stop sets a desired depth for the one or more cutting features to remove the bone by preventing the one or more cutting features from extending beyond the desired depth when the stop contacts the surface of the bone and the one or more cutting features are configured for cutting the bone with an initial plunging insertion of the apparatus into the bone axially along the centerline axis of the shaft. As to claim 8, Callahan is silent to the stop is constructed and arranged as a flange having a solid body or one or more spokes coupling the flange to the shaft.
Mikhail teaches a similar apparatus (40, Figs. 10, 11, and 14) capable of removing a desired amount of bone during an orthopedic procedure (Fig. 14), the apparatus comprising: a shaft (elongate portion shown defining a cannulation that receives 38 as shown in Fig. 14, i.e. 42 and central portion of 41 extending to 46C, Figs. 10, 11, and 14) having a centerline axis (x) and at least partially cannulated (Figs. 10, 11, and 14) at a distal end portion (lower portion as shown in Fig. 10); a stop (44A, portion of 44 between 43 and 44, Figs. 10, 11, and 14, col. 6 lines 23-27) coupled to the shaft at or adjacent the distal end portion (Figs. 10, 11, and 14), wherein the stop is capable of contacting a surface of the bone (Fig. 14, col. 6 lines 23-27); and one or more cutting features (left 46 as shown in Figs. 10 and 11, Figs. 10 and 11) coupled to the distal end portion and coupled to the stop (Fig. 10), wherein the one or more cutting features are capable of cutting the bone with rotation of the one or more cutting features about the centerline axis of the shaft (Fig. 14, col. 5 lines 51-55, col. 6 lines 37-40), wherein the stop sets a desired depth for the one or more cutting features to remove the bone (Fig. 14, col. 6 lines 23-27) by preventing the one or more cutting features from extending beyond the desired depth when the stop contacts the surface of the bone (Fig. 14, col. 6 lines 23-27), and wherein the one or more cutting features are capable of cutting the bone with an initial plunging insertion of the apparatus into the bone axially along the centerline axis of the shaft (Figs. 10 and 14, col. 6 lines 5-11 discloses that 46A, 46B, and 46C are each cutting edges of the blade), the one or more cutting features comprising a cutting edge (46A, 46B, and 46C) substantially parallel to an insertion axis (vertical as shown in Fig. 10, Figs. 10 and 14, col. 6 lines 5-11 discloses that 46A, 46B, and 46C are each cutting edges of the blade). As to claim 2, Mikhail teaches that the one or more cutting features comprise a single cutting feature (as defined, i.e. left 46 as shown in Figs. 10 and 11, Figs. 10 and 11). As to claim 8, Mikhail discloses that the stop is constructed and arranged as a flange (Figs. 10, 11, and 14) having a solid body or one or more spokes coupling the flange to the shaft (Fig. 11). As to claim 21, Mikhail teaches that wherein the one or more cutting features are constructed and arranged such that a single revolution of the shaft about the centerline axis removes a discrete bone segment that passes into an opening (due to the shown structure, Figs. 10, 11, and 14).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the stop as disclosed by Callahan to extend outwardly of the one or more cutting features a substantial distance, on the order of one to two millimeters, as taught by Mikhail in order to permit the stop to contact the natural glenoid and function as a stop for determining the proper depth of the cavity and insure against inadvertent reaming of the scapula to an excessive depth (Mikhail col. 6 lines 23-27). One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to specify/modify the one or more cutting features as disclosed by Callahan comprise a cutting edge substantially parallel to the insertion axis as taught by Mikhail in order to permit provide a known cutting edge (Mikhail Figs. 10 and 14, col. 5 lines 59-65, col. 6 lines 5-11) for reaming a glenoid (Mikhail Fig. 14, col. 6 lines 37-40; Callahan col. 2 lines 57-60).
As to claims 11, 13, and 22, Callahan discloses an apparatus (100, Figs. 1-3) capable of removing part of a humerus during an orthopedic shoulder procedure (if one so chooses where col. 2 lines 57-60 discloses use on a glenoid), the apparatus comprising: a shaft (116, 104, Fig. 2) having a centerline axis (horizontal and along the center of 116 as shown in Fig. 2, Fig. 2); a stop (102) extending from a distal end portion of the shaft (Figs. 1 and 2), the stop constructed and arranged such that the stop contacts a surface of a metaphysis of the humerus (if a such is so positioned, e.g. between 109a and 109d, if one so chooses, where such is disclosed for glenoid use in col. 2 lines 57-60); and one or more cutting features (109a) coupled to the distal end portion of the shaft distal of the stop (Figs. 1 and 2), and extending proximally and radially outward from the shaft relative to the centerline axis to couple with the stop (Fig. 2), wherein the one or more cutting features are constructed and arranged such that the one or more cutting features cut the metaphysis with rotation of the one or more cutting features about the centerline axis of the shaft (col. 3 lines 10-15 and 50-53), wherein the apparatus is inserted along an insertion axis (horizontal as shown in Fig. 2, Fig. 2). As to claim 13, Callahan discloses that the one or more cutting features comprise a single cutting feature (as defined, i.e.109a, Figs. 1 and 2). As to claim 22, Callahan discloses that wherein the one or more cutting features are constructed and arranged such that a single revolution of the shaft about the centerline axis removes a discrete bone segment that passes into the opening (due to the shown structure, Fig. 2).
Callahan is silent to the stop sets a desired depth for the one or more cutting features to remove the part of the humerus by preventing the one or more cutting features from extending beyond the desired depth when the stop contacts the surface of the metaphysis of the humerus and the one or more cutting features are configured for cutting the humerus with an initial plunging insertion of the apparatus into the humerus.
Mikhail teaches a similar apparatus (40, Figs. 10, 11, and 14) capable of removing part of a humerus during an orthopedic shoulder procedure (if one so chooses, where Fig. 14 shows use for removing part of a glenoid as described in col. 6 lines 35-45), the apparatus comprising: a shaft (elongate portion shown defining a cannulation that receives 38 as shown in Fig. 14, i.e. 42 and central portion of 41 extending to 46C, Figs. 10, 11, and 14) having a centerline axis (x); a stop (44A, portion of 44 between 43 and 44, Figs. 10, 11, and 14, col. 6 lines 23-27) extending from a distal end portion of the shaft (Figs. 10, 11, and 14), wherein the stop is constructed and arranged such that the stop contacts a surface of a metaphysis of the humerus (if one so chooses, where such is disclosed for glenoid use in Fig. 14, col. 6 lines 23-27); and one or more cutting features (left 46 as shown in Figs. 10 and 11, Figs. 10 and 11) coupled to the distal end portion of the shaft distal of the stop (Fig. 10) and extending proximally and radially outward from the shaft relative to the centerline axis to couple with the stop (in as much as Applicant’s, Figs. 10, 11, and 14), wherein the one or more cutting features are constructed and arranged such that the one or more cutting features cut the metaphysis with rotation of the one or more cutting features about the centerline axis of the shaft (Fig. 14, col. 5 lines 51-55, col. 6 lines 37-40), wherein the stop sets a desired depth for the one or more cutting features to remove the part of the humerus by preventing the one or more cutting features from extending beyond the desired depth when the stop contacts the surface of the metaphysis of the humerus (Fig. 14, col. 6 lines 23-27), and wherein the one or more cutting features are capable of cutting the bone with an initial plunging insertion of the apparatus into the humerus (Figs. 10 and 14, col. 6 lines 5-11 discloses that 46A, 46B, and 46C are each cutting edges of the blade), the one or more cutting features comprising a cutting edge (46A, 46B, and 46C) substantially parallel to an insertion axis (vertical as shown in Fig. 10, Figs. 10 and 14, col. 6 lines 5-11 discloses that 46A, 46B, and 46C are each cutting edges of the blade). As to claim 13, Mikhail teaches that the one or more cutting features comprise a single cutting feature (as defined, i.e. left 46 as shown in Figs. 10 and 11, Figs. 10 and 11). As to claim 22, Mikhail teaches that wherein the one or more cutting features are constructed and arranged such that a single revolution of the shaft about the centerline axis removes a discrete bone segment that passes into an opening (due to the shown structure, Figs. 10, 11, and 14).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the stop as disclosed by Callahan to extend outwardly of the one or more cutting features a substantial distance, on the order of one to two millimeters, as taught by Mikhail in order to permits the stop to contact the natural glenoid and function as a stop for determining the proper depth of the cavity and insure against inadvertent reaming of the scapula to an excessive depth (Mikhail col. 6 lines 23-27). One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to specify/modify the one or more cutting features as disclosed by Callahan comprise a cutting edge substantially parallel to the insertion axis as taught by Mikhail in order to permit provide a known cutting edge (Mikhail Figs. 10 and 14, col. 5 lines 59-65, col. 6 lines 5-11) for reaming a glenoid (Mikhail Fig. 14, col. 6 lines 37-40; Callahan col. 2 lines 57-60).
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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