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 January 26, 2026. As directed by the amendment: Claims 1, 3, 13, and 18 have been amended. Claims 8 and 15 have been cancelled. Claims 1-7, 9-14, and 16-22 are presently pending in this application.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-7, 9-14, and 16-22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1, ll. 10-11, the phrase “a tamp including a head and a shaft wherein the head has a cross-section larger than a cross-section of the shaft and is sized and shaped to pass through the window without the need for a guide” renders new matter as the originally filed disclosure is silent on the tamp sized and shaped to pass through the window without the need for a guide. The Examiner notes that such a limitation is considered a negative limitation, wherein it is an attempt to claim the invention by excluding what the inventor(s) did not invent rather than distinctly and particularly pointing out what the inventor(s) did invent. Applicant is suggested to cancel any new matter in order to overcome this rejection.
Regarding claim 13, ll. 14, the phrase “inserting a tamp directly through the window without a guide” renders new matter as the originally filed disclosure is silent on this feature. The Examiner notes that such a limitation is considered a negative limitation, wherein it is an attempt to claim the invention by excluding what the inventor(s) did not invent rather than distinctly and particularly pointing out what the inventor(s) did invent. Applicant is suggested to cancel any new matter in order to overcome this rejection.
Regarding claim 18, ll. 6, the phrase “inserting a tamp directly through a window extending through the bone plate without a guide” renders new matter as the originally filed disclosure is silent on this feature. The Examiner notes that such a limitation is considered a negative limitation, wherein it is an attempt to claim the invention by excluding what the inventor(s) did not invent rather than distinctly and particularly pointing out what the inventor(s) did invent. Applicant is suggested to cancel any new matter in order to overcome this rejection.
Claims 2-7, 9-12, 14, 16, 17, and 19-22 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 and 9-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over West (US 2020/0405435) in view of Vasta et al. (US 8,398,687), herein referred to as Vasta, and further in view of Kiritsis (US 2012/0053586).
Regarding claim 1, West discloses a bone plate system (figure 1A) comprising a bone plate (20) including an elongated shaft portion (34) and a head portion (36) connected to and monolithic with the elongated shaft portion (34) (figure 1A), the elongated shaft and head portions (34, 36) forming an angled portion (¶34) and including a bone contacting bottom surface (28) and an opposite top surface (26) (¶34), a hole (52) extending from the top surface (26) to the bone contacting bottom surface (28) (figure 1A), and a window (40) extending from the top surface (26) to the bone contacting bottom surface (28) (figure 1A), the window (40) defined on the angled portion (¶34).
Next, West discloses the plate body may assume other shapes and configurations, depending on the specific fracture treated by the surgeon (¶35). Yet, West lacks a detailed description on the elongated shaft and head portions forming an angled portion defining an angle of approximately 30 to 60 degrees therebetween.
Furthermore, Vasta teaches an elongated shaft and head portions (15, 20) forming an angled portion (figures 3a-3d) defining an angle of approximately 30 to 60 degrees therebetween (e.g. approximately 25 degrees, col. 5, ll. 28-34). In addition, Vasta teaches a wide range of dimensions may be appropriate and all are intended to be included within the scope (col. 5, ll. 28-34).
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 West’s bone plate with the elongated shaft and head portions forming an angled portion defining an angle of approximately 30 to 60 degrees therebetween as taught by Vasta, since such an angle would be appropriate for its intended use, wherein West clearly contemplates the plate body may assume other shapes and configurations, depending on the specific fracture treated by the surgeon (¶35). Furthermore, the prior art discovering optimum or workable ranges involves routine experimentation in the art.
The modified West’s bone plate system further lacks a tamp including a head and a shaft, wherein the head has a cross-section larger than a cross-section of the shaft and is sized and shaped to pass through the window without the need for a guide.
However, Kiritsis teaches a tamp (172) (¶44, ¶45) including a head (174) and a shaft (176), wherein the head (174) has a cross-section (figures 6 and 8) larger than a cross-section of the shaft (176) (figures 6 and 8) and is sized and shaped to (i.e. capable of) pass through a window without the need for a guide (the Examiner notes that elements 174+176 is capable of passing through a window 130 without the need for a guide 164).
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 West’s bone plate system with a tamp including a head and a shaft, wherein the head has a cross-section larger than a cross-section of the shaft and is sized and shaped to pass through the window without the need for a guide as taught by Kiritsis, since such a modification would deliver bone graft to the site for treatment (¶45).
Regarding claim 2, the modified West’s bone plate system has wherein the window (40 of West) includes an upper edge (figure 1A of West) and a lower edge (figure 1A of West) opposite the upper edge (figure 1A of West), and wherein the upper and lower edges (figure 1A of West) are positioned within the angled portion (¶34 of West) of the bone plate (the modified West’s bone plate).
Regarding claim 3, the modified West’s bone plate system has wherein the window (40 of West) is configured to (i.e. capable of) be used as an access point for the head of the tamp.
Regarding claim 4, the modified West’s bone plate system discloses all the features/elements as claimed but lacks a detailed description on wherein a perimeter of the window is at least twice as large as a perimeter of the hole.
However, a change in size is generally recognized as being within the level of ordinary skill in the art. Furthermore, West teaches the window (40) may be shaped with various letters, names, symbols or the like (¶38).
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 the modified West’s bone plate system with wherein a perimeter of the window is at least twice as large as a perimeter of the hole, since such a modification is considered a change in size that is generally recognized as being within the level of ordinary skill in the art.
Regarding claim 5, the modified West’s bone plate system has wherein the tamp (172 of Kiritsis) is configured to (i.e. capable of) be placed through the window (40 of West) at an angle within a range of 30-60 degrees with respect to the elongated shaft portion (34 of West).
Regarding claims 6, 7, the modified West’s bone plate system discloses all the features/elements as claimed but lacks wherein the window defines a length in a first proximal-distal direction and the window defines a width in a second direction orthogonal to the first direction, and wherein the width of the window changes along the length, wherein the width of the window along a proximal edge of the window is greater than the width of the window along a distal edge of the window, and the width of the window tapers as the window extends distally.
However, Vasta teaches a window (70) defines a length (figure 1) in a first proximal-distal direction (figure 1) and the window (70) defines a width in a second direction (figure 1) orthogonal to the first direction (figure 1), and wherein the width of the window (70) changes along the length (figure 1), wherein the width of the window along a proximal edge of the window (70) (figure 1) is greater than the width of the window along a distal edge of the window (70) (figure 1), and the width of the window (70) tapers as the window extends distally (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 the modified West’s bone plate system with wherein the window defines a length in a first proximal-distal direction and the window defines a width in a second direction orthogonal to the first direction, and wherein the width of the window changes along the length, wherein the width of the window along a proximal edge of the window is greater than the width of the window along a distal edge of the window, and the width of the window tapers as the window extends distally as taught by Vasta, since such a modification is considered a change in shape that is generally recognized as being within the level of ordinary skill in the art.
Regarding claims 9, 10, the modified West’s bone plate system discloses all the features/elements as claimed but lacks wherein at least a portion of a window edge extends parallel to a portion of an edge of the bone plate, wherein the window defines a window edge comprising straight portions connected by rounded portions.
Yet, West teaches the window (40) may be shaped with various letters, names, symbols or the like (¶38). Furthermore, Kiritsis teaches at least a portion of a window edge (e.g. edge of element 130) extends parallel to a portion of an edge of the bone plate (e.g. edge of element 102), wherein the window (130) defines a window edge (e.g. edge of element 130) comprising straight portions (figure 1) connected by rounded portions (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 the modified West’s bone plate system with wherein at least a portion of a window edge extends parallel to a portion of an edge of the bone plate, wherein the window defines a window edge comprising straight portions connected by rounded portions as taught by Kiritsis, since such a modification is considered a change in shape that is generally recognized as being within the level of ordinary skill in the art.
Regarding claims 11, 12, the modified West’s bone plate system discloses all the features/elements as claimed but lacks wherein a first pair of opposing straight portions among the straight portions of the window edge extend parallel to one another, wherein a second pair of opposing straight portions among the straight portions of the window edge extend oblique to one another.
However, a change in size is generally recognized as being within the level of ordinary skill in the art. Furthermore, West teaches the window (40) may be shaped with various letters, names, symbols or the like (¶38).
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 the modified West’s bone plate system with wherein a second pair of opposing straight portions among the straight portions of the window edge extend oblique to one another, since such a modification is considered a change in shape that is generally recognized as being within the level of ordinary skill in the art.
Response to Arguments
Applicant's arguments filed January 26, 2026 have been fully considered but they are not persuasive.
Applicant’s arguments on pages 6-7, under 35 U.S.C. 103, of the Remarks are directed to the amended claims 1, 13, 18 and the reference Kiritsis. Applicant’s amendments e.g. “without a guide” renders new matter as the originally filed disclosure is silent on this feature.
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