Detailed Action
This is the first office action on the merits for US application number 18/658,145.
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 .
Election/Restrictions
Applicant’s election without traverse of Invention I, the product of claims 1-14 in the reply filed on January 2, 2026 is acknowledged.
Applicant’s election without traverse of Species a), of Figs. 1-3C, in the reply filed on January 2, 2026 is acknowledged, which indicated that claims 1-4, 6-9, 11, 13, and 14 read on the elected species.
Claims 5, 10, 12, and 15-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
As to claim 6, the limitation of a proximal end portion of the shaft includes an impactor plate does not read on the elected species with coupling mechanism 128 can be formed as a male hexagonal projection or a female hexagonal recess for engaging with a male/female part of a driving instrument. Further, striking plate 219B is disclosed in paragraph 65 for non-elected species b), of Figs . 4-4B. Therefore, claim 6 does not read on the elected species.
Accordingly, claim 6 is withdrawn from further consideration along with claims 5, 10, 12, and 15-20.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 50. Examiner suggests amending Fig. 2 to change ‘50’ to ‘114’ as supported by paragraph 56.
The drawings are objected to under 37 CFR 1.83(a) because they fail to show guiding element 114 as described in the specification. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Examiner suggests amending Fig. 2 to change ‘50’ to ‘114’ as supported by paragraph 56.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim(s) 1 and 11 is/are objected to because of the following informalities:
Claim 1 line 1 should read “An apparatus for removing a bone during an orthopedic procedure, the apparatus comprising:”.
Claim 11 line 1 should read “An apparatus for removing part of a humerus during an orthopedic shoulder procedure, the apparatus comprising:”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 1-4, 7-9, 11, 13, and 14 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim(s) 1 is/are unclear with regards to “An apparatus for removing a bone during an orthopedic procedure” in line 1 and how such can be reasonably construed to be supported by Applicant’s specification and drawings. As disclosed in paragraph 57, usage of the Applicant’s reamer 100 allows a desired amount of the bone 104 to be removed with reaming using the one or more cutting features 122; however, there appears to be no disclosure of removing a bone nor do the devices shown in Applicant’s figures appear to be intended to perform such a function. Examiner is interpreting this as referring to, and suggests amending as, “An apparatus for removing a desired amount of bone during an orthopedic procedure”.
Claim(s) 8 is/are unclear with regards to “more spokes” in line 2 and what “more” is relative to or how many is intended to be claimed. Examiner is interpreting this as referring to, and suggests amending as, “a flange having
Claim(s) 11 is/are unclear with regards to the one or more cutting features “extending proximally and radially outward from the centerline axis to couple with the stop” in lines 6-7 and how the disclosed cutting feature can be reasonably described to extend proximally and radially outward from the centerline axis when the axis is along a cannulation and not a structure and the axis defines the directions of proximal/distal and how a structure can extend proximally if the end of the shaft is distally and the axis defines proximal/distal. Examiner is interpreting this broadly as the one or more cutting features extending radially outwardly from the shaft and suggests amending to clarify.
Claim(s) 2-4, 7, 9, 13, and 14 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for its/their dependence on one or more rejected base claims.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 2, 7-9, 11, and 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mikhail (US 5,489,310).
As to claim 1, Mikhail discloses an 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).
As to claim 2, Mikhail discloses 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 7, Mikhail discloses that 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).
As to claim 8, Mikhail discloses that the stop is configured as a flange (Figs. 10, 11, and 14) having a solid body or spokes coupling the flange to the shaft (Fig. 11).
As to claim 9, Mikhail discloses that the distal end portion extends distal of the stop (as defined, Figs. 10 and 14).
As to claim 11, Mikhail discloses an 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 capable of contacting 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 distal of the stop (Fig. 10) and extending proximally and radially outward from 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 capable of cutting 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).
As to claim 14, Mikhail discloses that the one or more cutting features are capable of cutting the humerus 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).
Claim(s) 11 and 13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Callahan et al. (US 11,123,086, hereinafter “Callahan”).
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 claim 11, 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 capable of contacting 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 distal of the stop (Figs. 1 and 2), and extending proximally and radially outward from the centerline axis to couple with the stop (Fig. 2), wherein the one or more cutting features are capable of cutting 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).
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), and wherein an opening (Fig. 2) is formed between the one or more cutting features, the distal end portion, and the stop (Fig. 2).
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) 1-4, 11, and 13 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 1-4, 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). 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 3, Callahan discloses that an opening (Fig. 2) is formed between the one or more cutting features, the distal end portion, and the stop (Fig. 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).
Callahan is silent to the stop sets a desired depth for the one or more cutting features to remove the bone.
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) .
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).
As to claims 11 and 13, 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 capable of contacting 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 distal of the stop (Figs. 1 and 2), and extending proximally and radially outward from the centerline axis to couple with the stop (Fig. 2), wherein the one or more cutting features are capable of cutting 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). 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), and wherein an opening (Fig. 2) is formed between the one or more cutting features, the distal end portion, and the stop (Fig. 2).
Callahan is silent to the stop sets a desired depth for the one or more cutting features to remove the bone.
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 capable of contacting 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 distal of the stop (Fig. 10) and extending proximally and radially outward from 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 capable of cutting 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).
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).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY R SIPP whose telephone number is (313)446-6553. The examiner can normally be reached on Mon - Thurs 6-4.
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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