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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 12, 2026 has been entered.
Status of the Claims
This Office Action is responsive to the amendment filed March 12, 2026. As directed by the amendment: Claims 36-40, 42-48, and 50-65 have been amended. Claims 1-35 have been cancelled. Claims 66 and 67 are newly added. Claims 36-67 are presently pending in this application.
Claim Objections
Claim 36 is objected to because of the following informalities: In ll. 2, the phrase “is between is between” should be re-written as --is between--. Appropriate correction is required.
Claim 66 is objected to because of the following informalities: In ll. 12, the phrase “such that first lobe” should be re-written as --such that the first lobe--. Appropriate correction is required.
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.
Claim(s) 50-55, 66, and 67 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Biedermann et al. (US 5,964,762), herein referred to as Biedermann.
Regarding claim 66, Biedermann discloses a device (figure 1) for fixing a bone in a growth plate area (considered functional), comprising a unitary body (1) having a first lobe (defined as “any projection or division” by the Dictionary) (see figure 1 below) defining a first local longitudinal axis (see figure 1 below) and a first elongate aperture (3), a second lobe (defined as “any projection or division” by the Dictionary) (see figure 1 below) defining a second local longitudinal axis (see figure 1 below) and a second elongate aperture (4), and an intermediate portion (see figure 1 below) disposed between and joining the first lobe (defined as “any projection or division” by the Dictionary) (see figure 1 below) and the second lobe (defined as “any projection or division” by the Dictionary) (see figure 1 below), the intermediate portion (see figure 1 below) defining a central longitudinal axis (see figure 1 below), wherein the first local longitudinal axis of the first lobe (see figure 1 below) and the second local longitudinal axis of the second lobe (see figure 1 below) are laterally offset from one another (see figure 1 below) and from the central longitudinal axis (see figure 1 below) such that the first lobe (defined as “any projection or division” by the Dictionary) (see figure 1 below) and the second lobe (defined as “any projection or division” by the Dictionary) (see figure 1 below) are non-collinear (see figure 1 below), the first local longitudinal axis (see figure 1 below) and the second longitudinal axis (see figure 1 below) are oriented within at most 5 degrees of each other (see figure 1 below), and the first elongate aperture (3) and the second elongate aperture (4) are shaped to receive screws (elements 17) that are configured to (i.e. capable of) travel along the local longitudinal axes as a result of bone growth (considered functional).
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Regarding claim 67, Biedermann discloses a device (figure 1) for fixing a bone in a growth plate area (considered functional), comprising a unitary body (1) having a first portion (see figure 1 below) having a pair of longitudinally extending edges (see figure 1 below), the first portion (see figure 1 below) defining a first local longitudinal axis (see figure 1 below) and a first elongate aperture (3), and a second portion (see figure 1 below) having a pair of longitudinally extending edges (see figure 1 below), the second portion (see figure 1 below) defining a second local longitudinal axis (see figure 1 below) and a second elongate aperture (4), wherein the pair of longitudinally extending edges of the first portion (see figure 1 below) are laterally offset (see figure 1 below) relative to the pair of longitudinally extending edges of the second portion (see figure 1 below), the first local longitudinal axis (see figure 1 below) and the second local longitudinal axis (see figure 1 below) are oriented within at most 5 degrees of each other (see figure 1 below), and the first elongate aperture (3) and the second elongate aperture (4) are shaped to (i.e. capable of) receive screws (elements 17) that are configured to (i.e. capable of) travel along the longitudinal axes as a result of bone growth (considered functional).
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Regarding claim 50, Biedermann discloses wherein the first local longitudinal axis of the first elongate aperture (3) mirrors the second local longitudinal axis of the second elongate aperture (4) across an axis in a longitudinal plane of the device (see figure 1 above).
Regarding claim 51, Biedermann discloses wherein the first and second local longitudinal axes of the first elongate aperture (3) and the second elongate aperture (4) are essentially parallel in a longitudinal plane of the device (see figure 1 above).
Regarding claim 52, Biedermann discloses wherein a shape of the first elongate aperture (3) or the second elongate aperture (4) is stadium shaped (see figure 1 above).
Regarding claim 53, Biedermann discloses wherein a shape of the first elongate aperture (3) or the second elongate aperture (4) is a rectangle (see figure 1 above).
Regarding claim 54, Biedermann discloses wherein a shape of the first elongate aperture (3) or the second elongate aperture (4) is curved in a longitudinal plane of the device (see figure 1 above).
Regarding claim 55, Biedermann discloses wherein unitary body is one of z-shaped, 8-shaped, hourglass shaped, double trapezoid shaped, or formed of a plurality of parallelograms (see figure 1 above).
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) 36, 39, 41-49, and 57 is/are rejected under 35 U.S.C. 103 as being unpatentable over Biedermann (US 5,964,762).
Regarding claim 36, Biedermann’s device discloses all the features/elements as claimed but lacks a detailed description on wherein a length of the intermediate portion is between 0.25 and 5.0 cm.
However, the prior art discovering optimum or workable ranges involves routine experimentation in the art.
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 Biedermann’s device with wherein a length of the intermediate portion is between 0.25 and 5.0 cm, since such a modification is considered optimization of the size of the prior art. Furthermore, it would be patient dependent.
Regarding claims 39, 41, Biedermann’s device discloses all the features/elements as claimed including wherein the device (1) has a connection axis passing through a mid-point of each end face of first and second elongate apertures (3, 4) facing towards each other (see figure 1 above), and wherein the first local longitudinal axis of the first elongate aperture (3) forming a first opening angle with the connection axis (figure 1), and the second local longitudinal axis of the second elongate aperture (4) forming a second opening angle with the connection axis (figure 1) but lacks wherein the first opening angle and the second opening angle are formed opposite each other relative connection axis and are each between 20 and 150 degrees, wherein the first opening angle and the second opening angle are each less than 155 degrees.
However, the prior art discovering optimum or workable ranges involves routine experimentation in the art.
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 Biedermann’s device with wherein the first opening angle and the second opening angle are formed opposite each other relative connection axis and are each between 20 and 150 degrees, wherein the first opening angle and the second opening angle are each less than 155 degrees, since such a modification is considered optimization of the size of the prior art. Furthermore, it would be patient dependent.
Regarding claims 42, 43, 44, 45, 46, 47, 48, Biedermann’s device discloses all the features/elements as claimed but lacks a detailed description on wherein the first and second elongate apertures each have a length at least two times their largest width, wherein the first and second elongate apertures each have a length at least three times their largest width, wherein the first and second elongate apertures each have a length between 0.5 cm and 10.0 cm, wherein the first and second elongate apertures each have a largest width between 2.0 mm and 6.0 mm, wherein a length of the device is between 2.0 cm and 6.0 cm, wherein a length of each of the first and second elongate apertures is at least one third of the length of the device, wherein a combined area of said first and second elongate apertures in a longitudinal plane of the device comprises at least 50% of the combined area of said first and second lobes in the longitudinal plane of the device.
However, the prior art discovering optimum or workable ranges involves routine experimentation in the art.
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 Biedermann’s device with wherein the first and second elongate apertures each have a length at least two times their largest width, wherein the first and second elongate apertures each have a length at least three times their largest width, wherein the first and second elongate apertures each have a length between 0.5 cm and 10.0 cm, wherein the first and second elongate apertures each have a largest width between 2.0 mm and 6.0 mm, wherein a length of the device is between 2.0 cm and 6.0 cm, wherein a length of each of the first and second elongate apertures is at least one third of the length of the device, wherein a combined area of said first and second elongate apertures in a longitudinal plane of the device comprises at least 50% of the combined area of said first and second lobes in the longitudinal plane of the device, since such a modification is considered optimization of the size of the prior art. Furthermore, it would be patient dependent.
Regarding claim 49, the modified Biedermann’s device has wherein the first opening angle (see figure 1 above) and the second opening angle (see figure 1 above) are essentially equal (see figure 1 above).
Regarding claim 57, Biedermann’s device discloses all the features/elements as claimed but lacks wherein the device is formed in a curve along a length of the device from the first distal end to the second distal end, the curve having a radius of curvature between 1.5 cm and 7.0 cm.
However, a change in shape is generally recognized as being within the level of ordinary skill in the art. Furthermore, the prior art discovering optimum or workable ranges involves routine experimentation in the art.
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 Biedermann’s device with wherein the device is formed in a curve along a length of the device from the first distal end to the second distal end, the curve having a radius of curvature between 1.5 cm and 7.0 cm, 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. Furthermore, the prior art discovering optimum or workable ranges involves routine experimentation in the art. Lastly, it would be patient dependent.
Claim(s) 56 and 59 is/are rejected under 35 U.S.C. 103 as being unpatentable over Biedermann (US 5,964,762) in view of Schelling (US 2011/0224734).
Regarding claims 56, 59, Biedermann’s device discloses all the features/elements as claimed including wherein the device (1) is made in a single piece (figure 1) but lacks wherein the device is formed of one or more of the following materials: stainless steel (SS), cobalt base alloys, bioceramics, titanium alloys, pure titanium, composite materials, and polymers or made of metal.
However, Shelling teaches a bone plate (100) made of a metal such as titanium alloys or stainless steel (¶55).
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 Biedermann’s device with wherein the device is made of metal such as titanium alloys or stainless steel as taught by Shelling, since such materials are biocompatible (¶55).
Allowable Subject Matter
Claims 37, 38, 40, 58, and 60-65 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant's arguments filed March 12, 2026 have been fully considered but they are not persuasive.
Applicant’s arguments on pages 10-12, under 35 U.S.C. 102(a)(1) and 35 U.S.C. 103, of the Remarks are directed to newly added independent claim 66. Applicant argues that Biedermann fails to expressly or inherently disclose "the first longitudinal axis of the first lobe and the second longitudinal axis of the second lobe are laterally offset from one another and from the central longitudinal axis such that first lobe and the second lobe are non-collinear". However, the Examiner respectfully disagrees because as generally claimed, Biedermann discloses wherein the first local longitudinal axis of the first lobe (see figure 1 above) and the second local longitudinal axis of the second lobe (see figure 1 above) are laterally offset from one another (see figure 1 above) and from the central longitudinal axis (see figure 1 above) such that the first lobe (defined as “any projection or division” by the Dictionary) (see figure 1 above) and the second lobe (defined as “any projection or division” by the Dictionary) (see figure 1 above) are non-collinear (see figure 1 above).
Conclusion
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/SI MING KU/Primary Examiner, Art Unit 3775