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 .
Status of the Claims
This Office Action is responsive to the amendment filed December 5, 2025. As directed by the amendment: Claims 1, 7, 10, 12, 14, and 20 have been amended. Claims 8, 13, 17, and 18 have been cancelled. Claims 21-24 are newly added. Claims 1-7, 9-12, 14-16, and 19-24 are presently pending in this application.
Specification Objections
The disclosure is objected to because of the following informalities: In paragraph 30, element 144 is labeled both as a mounting tab and a mounting recess. Appropriate correction is required.
Claim Objections
Claim 1 is objected to because of the following informalities: In ll. 11, the phrase “the slot” should be re-written as --the cutting slot--. Appropriate correction is required.
Claim 21 is objected to because of the following informalities: It appears claim 21 is dependent on itself and should be dependent from claim 20 instead. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
Claims 1-7, 9-12, and 14-16 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the first guide portion" in ll. 9. There is insufficient antecedent basis for this limitation in the claim.
Claims 2-7, 9-12, and 14-16 are rejected on being dependent to a rejected base claim.
Examiner’s Note
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1-7, 12, and 14-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Park et al. (US 2009/0222016), herein referred to as Park, and in view of Metzger et al. (US 2019/0374237), herein referred to as Metzger.
Regarding claim 1, Park discloses an orthopedic surgical assembly (5) (e.g. figures 2A, 2F) configured to (i.e. capable of) be received on a neck of a femur (¶30 and figure 2A) between a ball and a shaft of the femur (¶30 and figure 2A), comprising a base portion (see figure 2F below) including a body portion (see figure 2F below) defining a contoured recess (see figure 2F below), wherein the contoured recess (see figure 2F below) is configured to (i.e. capable of) be received adjacent a portion of the neck of the femur (figure 2A).
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Yet, Park lacks a first guide plate including a mounting tab and a cutting slot, the mounting tab being configured to be selectively coupled to the base portion so that the cutting slot is disposed adjacent the neck of the femur in a first position. However, Park teaches the orthopedic surgical assembly (5) may have a multi-piece construction, for example, the saw slot 1725 may be in the form of a separate guide that is mounted to the rest of the tool (5) (¶64).
In addition, Metzger teaches a first guide plate (16) including a mounting tab (34) and a cutting slot (48), the mounting tab (34) being configured to (i.e. capable of) be selectively coupled to a base portion (24) (figure 1).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Park’s orthopedic surgical assembly with a first guide plate including a mounting tab and a cutting slot, the mounting tab being configured to be selectively coupled to a base portion as taught by Metzger, since such a modification would provide an alternative construction, wherein Park clearly contemplates the assembly may have a multi piece construction.
Thus, the modified Park’s orthopedic surgical assembly has the mounting tab (34 of Metzger) being configured to (i.e. capable of) be selectively coupled to the base portion (the modified Park’s base portion) so that the cutting slot (1725 of Park) is disposed adjacent the neck of the femur in a first position (figure 2A of Park), wherein the first guide plate (the modified Park’s first guide plate) is configured for (i.e. capable of) use with different patients (considered functional), wherein, when (considered functional) the mounting tab (34 of Metzger) of the first guide portion is coupled to the base portion (the modified Park’s base portion), the base portion (the modified Park’s base portion) is configured for (i.e. capable of) complementary receipt against the portion of the neck of the femur so that the slot is positioned between the ball of the femur and an entirety of the contoured recess along an axis extending between the mounting tab and the cutting slot of the first guide plate (considered functional).
Regarding claim 2, the modified Park’s orthopedic surgical assembly has wherein the body portion of the base portion (the modified Park’s base portion) further defines a mounting recess (figure 1 of Metzger), wherein the mounting tab (34 of Metzger) is configured to (i.e. capable of) be received within the mounting recess (figures 1 and 2 of Metzger).
Regarding claim 3, the modified Park’s orthopedic surgical assembly has wherein the base portion (the modified Park’s base portion) further comprises a pair of projections (elements 36 of Metzger) extending from the body portion (figure 1 of Metzger), each projection having a side wall (figure 1 of Metzger), wherein a base wall (figure 1 of Metzger) extends between the side walls of the projections (elements 36 of Metzger) and defines the mounting recess (figure 1 of Metzger).
Regarding claim 4, the modified Park’s orthopedic surgical assembly has wherein the contoured recess (see figure 2F of Park above) includes a mounting surface (see figure 2F of Park above) that is conformed to a portion of an outer surface of the neck of the femur (figure 2A of Park).
Regarding claim 5, the modified Park’s orthopedic surgical assembly has wherein the mounting surface of the contoured recess (see figure 2F of Park above) is patient-specific (¶117 of Park), wherein mounting surface of the contoured recess is based on a medical image (¶117 of Park).
Regarding claim 6, the modified Park’s orthopedic surgical assembly has wherein the mounting surface of the contoured recess (see figure 2F of Park above) extends between a pair of legs (elements 36 of Metzger) that extend from the base portion (the modified Park’s base portion).
Regarding claim 7, the modified Park’s orthopedic surgical assembly has further comprising at least one fixing aperture (1715 of Park) defined in a distal end the first guide plate (the modified Park’s first guide plate) and a fixing pin (e.g. anchor, ¶60 of Park) that is configured to (i.e. capable of) pass through the at least one fixing aperture of the first guide plate and be inserted into the ball of the femur (considered functional).
Regarding claim 12, the modified Park’s orthopedic surgical assembly has wherein the first guide plate (the modified Park’s first guide plate) is configured to (i.e. capable of) be sterilized and reused in a surgery performed on a femur of a different patient (considered functional).
Regarding claim 14, the modified Park’s orthopedic surgical assembly has wherein the contoured recess (see figure 2F of Park above) is configured to (i.e. capable of) be received on the neck of the femur at a first location that is spaced between the neck and an intertrochanteric line of the femur (figure 2A of Park), wherein the first location is at a narrowest portion of the neck of the femur (figure 2A of Park).
Regarding claim 15, the modified Park’s orthopedic surgical assembly has wherein the cutting slot (1725 of Park) of the first guide plate (the modified Park’s first guide plate) is configured to (i.e. capable of) permit receipt of a saw at a predetermined angle (¶62 of Park).
Regarding claim 16, the modified Park’s orthopedic surgical assembly is capable of having wherein the predetermined angle is 90° to a longitudinal axis of the neck of the femur (considered functional).
Claim(s) 9 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Park and Metzger as applied to claim 1 above, and further in view of Williams, III et al. (US 7,621,919), herein referred to as Williams, III.
Regarding claims 9, 10, the modified Park’s orthopedic surgical assembly discloses all the features/elements as claimed but lacks a detailed description on wherein the base portion comprises a first material, wherein the first guide plate comprises a second material that is different from the first material, wherein the first material is a biocompatible polymer and the second material is a biocompatible metal.
However, Williams, III teaches wherein a base portion (12) comprises a first material (e.g. polymeric, col. 3, ll. 44-52), wherein a first guide plate (14) comprises a second material (e.g. metal, col. 4, ll. 65-67 and col. 5, ll. 1-13) that is different from the first material (e.g. polymeric, col. 3, ll. 44-52), wherein the first material is a biocompatible polymer (e.g. polymeric, col. 3, ll. 44-52) and the second material is a biocompatible metal (e.g. metal, col. 4, ll. 65-67 and col. 5, ll. 1-13).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the modified Park’s orthopedic surgical assembly with wherein the base portion comprises a first material, wherein the first guide plate comprises a second material that is different from the first material, wherein the first material is a biocompatible polymer and the second material is a biocompatible metal as taught by Williams, III, since such materials are easy to utilize in manufacturing (col. 3, ll. 50-52 and col. 5, ll. 8-9).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Park and Metzger as applied to claim 1 above, and further in view of Sanchez Alvarez et al. (US 2022/0313286), herein referred to as Sanchez Alvarez.
Regarding claim 11, the modified Park’s orthopedic surgical assembly discloses all the features/elements as claimed but lacks a detailed description on wherein the base portion is 3D printed.
However, Sanchez Alvarez teaches a guide (1, 2, 3, 4) (includes a base portion) is 3D printed (¶66).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the modified Park’s orthopedic surgical assembly with wherein the base portion is 3D printed as taught by Sanchez Alvarez, since such a method allows the sustainable manufacturing of components at tightened costs (¶66).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Park (US 2009/0222016) in view of Metzger (US 2019/0374237) and further in view of Dodds et al. (US 9,005,207), herein referred to as Dodds.
Regarding claim 19, Park discloses an orthopedic surgical assembly (5) (e.g. figures 2A, 2F) configured to (i.e. capable of) be received on a neck of a femur (¶30 and figure 2A) between a ball and a shaft of the femur (¶30 and figure 2A), comprising a base portion (see figure 2F above) including a body portion (see figure 2F above) defining a contoured recess (see figure 2F above), wherein the contoured recess (see figure 2F above) is configured to (i.e. capable of) be received adjacent a portion of the neck of the femur (figure 2A).
Yet, Park lacks a first guide plate defining a cutting slot, the first guide plate being configured to be selectively secured to the base portion so that the cutting slot is disposed adjacent the neck of the femur in a first position. However, Park teaches the orthopedic surgical assembly (5) may have a multi-piece construction, for example, the saw slot 1725 may be in the form of a separate guide that is mounted to the rest of the tool (5) (¶64).
In addition, Metzger teaches a first guide plate (16) defining a cutting slot (48) (figure 1), the first guide plate (16) being configured to be selectively secured to a base portion (24) (figure 1).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Park’s orthopedic surgical assembly with a first guide plate defining a cutting slot, the first guide plate being configured to be selectively secured to the base portion as taught by Metzger, since such a modification would provide an alternative construction, wherein Park clearly contemplates the assembly may have a multi piece construction.
Thus, the modified Park’s orthopedic surgical assembly has the first guide plate (the modified Park’s first guide plate) being configured to (i.e. capable of) be selectively secured to the base portion (the modified Park’s base portion) so that the cutting slot (1725 of Park) is disposed adjacent the neck of the femur in a first position (figure 2A of Park).
The modified Park’s orthopedic surgical assembly further lacks a kit having a second guide plate defining a cutting slot, the second guide plate being configured to be selectively secured to the base portion so that the cutting slot is disposed adjacent the neck of the femur in a second position, wherein the second position differs from the first position.
However, Dodds teaches a kit having multiple guide plates (720, 724, 728) (figures 22D-22F) with different cutting slots (722, 726, 730) (e.g. second position differs from a first position) (figures 22D-22F).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the modified Park’s orthopedic surgical assembly with a kit having a second guide plate defining a cutting slot as taught by Dodds, since such a modification would provide alternative cut positions (col. 17, ll. 32-50).
Allowable Subject Matter
Claims 20-24 are allowed.
The following is a statement of reasons for the indication of allowable subject matter: After further search and consideration it is determined that the prior art of record neither anticipated nor renders obvious the claimed subject matter of the instant application as a whole either taken alone or in combination, in particular, the prior art of record does not teach, the following limitation(s) in combination with the remaining claimed limitation such as but not limited to “A method of using an orthopedic surgical assembly, the method comprising coupling a base portion to a first guide plate, wherein the base portion includes a body portion defining a contoured recess, wherein the contoured recess is configured to be received adjacent a portion of a neck of a femur, wherein the first guide plate including a mounting tab and a cutting slot, the mounting tab being configured to be selectively coupled to the base portion so that the cutting slot is disposed adjacent the neck of the femur in a first position; positioning the contoured recess against a neck of a femur between a ball and a shaft of the femur so that the cutting slot is positioned between the ball of the femur and an entirety of the contoured recess along an axis extending between the mounting tab and the cutting slot of the first guide plate”.
Response to Arguments
Applicant's arguments filed December 5, 2025 have been fully considered but they are not persuasive.
Applicant’s arguments on pages 6-11, under 35 U.S.C. 103, of the Remarks are directed to the amended claims and the combination of references (Park, Metzger, Dodds). Applicant argues on pages 7-10 of the Remarks that “Accordingly, both Park and Metzger fail to disclose a guide plate that is suitable for use with different patients. Applicant submits that Park and Metzger both rely on patient-specific components as a fundamental requirement of their disclosed principles of operation. In particular, both Park and Metzger require that the structure defining the cutting guide be patient-specific. Thus, modification of Park to arrive at the claimed combination-requiring that the first guide plate be configured for use with different patients-would have fundamentally changed the principle of operation of Park. For at least this reason, modification of Park to arrive at the claimed combination would not have been obvious.” In response to applicant's argument that “both Park and Metzger fail to disclose a guide plate that is suitable for use with different patients”, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The Examiner further notes that claim 1 is directed to a device rather than a method.
Applicant argues on page 11 of the Remarks with respect to claim 19 that “Park is fundamentally directed to a tool wherein the cutting slot is intentionally placed in a specific spot for that specific patient. Metzger, similarly, has a patient specific slot placed in a patient-specific second portion. Accordingly, unlike Dodd, which is patient-non-specific, the device of Park, even as modified by Metzger, would have already been optimized for the particular patient and, therefore, would have had no reason for further modification to include different components with different slots”. In response to applicant's argument that “both Park and Metzger are directed to tools that are, in their entirety, patient specific”, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The Examiner further notes that claim 19 is directed to a kit rather than a method.
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.
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/SI MING KU/Primary Examiner, Art Unit 3775