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 .
Response to Amendment
This Office Action is responsive to the amendment filed on 16 March 2026. As directed by the amendment: claims 1, 16, 21, and 22 have been amended, claims 7, 10, 11, 13, and 19 are cancelled, and claims 28-30 are newly added. Claims 1-6, 8, 9, 12, 14-18, and 20-30 currently stand pending in the application.
The amendments to the claims are sufficient to overcome the rejections under 35 U.S.C. 112(b) listed in the previous action, which are accordingly withdrawn.
Response to Arguments
Applicant's arguments, filed 16 March 2026, as to the rejections under 35 U.S.C. 102(a)(1)/(2), have been fully considered but they are not persuasive. Applicant contends that Galm’s (US 9,370,386) curved expanded section (upper left corner) and outcropped section (upper right corner) of the bone plate appear to terminate at laterally outermost locations that are about equidistant from the longitudinal axis of the plate when measured perpendicular to the longitudinal axis. Examiner respectfully submits that the limitations are being interpreted as being recited individually, such that the curved expanded section protrudes outwardly in a first direction (to the left) from the longitudinal axis, and also terminates at a first (laterally) outermost location, such that the curved expanded section terminates laterally at a location on the peripheral edge on the upper left of the head portion, e.g. a laterally outermost location near where the curved protruding left corner meets the straight angled left section. The outcropped section protrudes outwardly in a second opposite direction (to the right) from the longitudinal axis, and also terminates at a second (proximally) outermost location, such that the outcropped section terminates proximally at a location on the peripheral edge on the upper right of the head portion, e.g. a proximally outermost location furthest from the shaft portion. Then, the first distance, which is measured from the first laterally outermost location on the upper left to a point on the longitudinal axis along an axis perpendicular to the longitudinal axis, is greater than the second distance, which is measured from the second proximally outermost location on the upper right to a point on the longitudinal axis along an axis perpendicular to the longitudinal axis. Each section can have lateral and proximal outermost locations since they are three-dimensional structures.
As to US 2021/0338293 to Silva et al., Applicant contends that the ears 38, 40 terminate at outermost locations that are about laterally equidistant from the longitudinal axis of the plate. Examiner respectfully submits that the curved expanded section (40) protrudes outwardly in a first direction (to the right) from the longitudinal axis A4 and the outcropped section (38) protrudes outwardly in a second opposite direction (to the left) from the longitudinal axis A4 (as seen in a small portion of 38 being on the left of A4); since only a small portion of 38 is on the left of the longitudinal axis A4, its laterally outermost point is closer to the longitudinal axis. The first distance is measured from the laterally outermost point on the right outer edge of 40 perpendicularly relative and back to the longitudinal axis, and the second distance is measured from the point on the left outer edge of 38 on the left side of the longitudinal axis perpendicularly relative and back to the longitudinal axis.
Applicant contends that the limitation “the first distance and the second distance are lateral distances measured perpendicular to the longitudinal axis” clarifies that both distances must be measured along the same lateral axis relative to the longitudinal axis of the plate. Examiner respectfully disagrees that the limitation requires both distances to be measured along the same lateral axis relative to the longitudinal axis of the plate. The first distance and the second distance need only be lateral distances (measured laterally) that are measured perpendicular to the longitudinal axis, and since the longitudinal axis extends infinitely in either direction, each distance can be measured laterally and perpendicularly to the longitudinal axis without necessarily being along the same lateral axis. In other words, each outermost location may be along an axis perpendicular to the longitudinal axis that intersects the longitudinal axis at different locations to each other. As to Galm, even if the second outermost location is the proximally outermost location, this location or point can be measured back to the longitudinal axis along an axis perpendicular to the longitudinal axis.
Applicant's arguments, filed 16 March 2026, as to the rejections under 35 U.S.C. 103, have been fully considered but they are not persuasive. Applicant contends that Galm’s viewing window is not fully capable of accommodating a condyle if the plate were applied to a distal humerus, because amended claim 1 requires the hole to be dimensioned to receive a portion of the condyle. Applicant contends that the term “dimensioned” is a structural requirement that demands a physical geometry corresponding to the anatomy of the condyle, not a hole that could hypothetically overlap part of a condyle. Examiner respectfully submits that Galm’s viewing window/hole is dimensioned to receive at least a portion of a condyle of a humerus. The dimensions of the viewing window/hole are such that at least a portion of a condyle is fully capable of being received therein, since the dimensions include a length and a width that result in an open negative space that can receive a portion of any bone therein. At least a portion of a condyle could include any portion, even minimal, of a condyle. The dimensions of a smaller hole would receive a condyle of a smaller patient. The dimensions or measurements of the hole are such that an appropriately and complementarily sized portion of the condyle can be received therein. A condyle is not a precise ellipse since a patient bone has natural irregularities, and thus as long as the general shape of the hole in Galm would be capable of receiving some portion of the condyle (or any bone), Galm meets the claim and is dimensioned to receive at least a portion of a condyle as much as the instant invention. The dimensions of the hole in Galm thus structurally enable the hole to be capable of receiving at least a portion of a condyle.
As to the intended use of the elliptical hole to accommodate at least a portion of a condyle of a distal humerus, Examiner respectfully submits that the plate in Galm is not modified to incorporate an elliptical hole that is specifically provided to accommodate a distal humeral condyle, but rather is modified to make the already disclosed hole in the plate in Galm of an elliptical shape, which shape is also contemplated by Galm. Then, the plate as modified to have an elliptical hole is fully capable of the intended use of accommodating at least a portion of a condyle of a distal humerus of an animal if and when the plate is applied to the distal humerus such that the hole extends over the condyle so that at least a portion of the condyle is accommodated therein. At least a portion of a condyle could include any portion, even minimal, of a condyle. The bone is fully capable of being any bone including but not limited to a distal humerus of an animal, with the dimensions of the plate made complementary. Since the hole is fully capable of accommodating at least a portion of a condyle, this would provide an anatomic fit of the bone plate relative to the distal humerus since at least a portion of the protruding condyle would be accommodated by the hole so the rest of the plate fits more flush against the bone.
Applicant contends as to Huebner (US 2005/0240187) that modifying the opening 48 to be an elliptical hole would not result in an elliptical hole that is dimensioned to accommodate a condyle of a distal humerus. Examiner respectfully submits that this is language of intended use, and deemed anticipated by the prior art if capable of said intended use. The plate is fully capable of application onto any bone of appropriate size, including a distal humerus. The elliptical hole is then fully capable of accommodating, in size and shape, i.e. dimensions, at least a portion of a condyle of a distal humerus of an animal when the plate is applied to the distal humerus such that the hole extends over the condyle so that at least a portion of the condyle is accommodated therein. Examiner notes that the limitation “at least a portion of a condyle” allows for any small portion, even minute, of the condyle to be accommodated. The suture hole 48 in Huebner is fully capable of accommodating at least a portion of a condyle, regardless of the hole shape, since any hole could accommodate at least a portion (where this portion could be miniscule) of a condyle when placed thereover. The changing of the shape is not required for accommodating the at least a portion of a condyle, but since it is disclosed as a shape option in Huebner and providing the hole in an elliptical shape would provide fewer stress points than other shapes and would not fray any sutures received therein.
Further as to Huebner, Applicant contends that Huebner’s straight section is not straight and not parallel to the longitudinal axis. Examiner directs attention to the annotated figure included in the below rejection, which shows a straight section of the peripheral edge which is on a left side of the plate as shown.
Applicant contends that Huebner’s second, third, and fourth openings are not adjacent to the straight section but proximal to the straight section. Examiner respectfully submits that being proximal to the straight section does not mean that the openings are not also adjacent to the straight section. Adjacent means next to; the second, third, and fourth openings are next to the straight section and not in the straight section, and closer to the straight section than to the shaft portion, for example.
Applicant’s arguments with respect to the rejections over Huebner in view of Esser (US 6,096,040) have been considered but are moot because the new ground of rejection does not rely on any combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Objections
Claims 1-6, 8, 9, 12, 14, 15, and 27 are objected to because of the following informalities: language. Appropriate correction is required. The following amendments are suggested:
Claim 1 / line 8: “the condyle is configured to be received”
Claim 1 / line 9: “the bone contacting surface is configured to seat against”
Claim Rejections - 35 USC § 112
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.
Claim 28 is rejected under 35 U.S.C. 112(a) 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.
As to claim 28, the limitation that a major axis of the elliptical hole extends at a transverse angle relative to the longitudinal axis of the bone plate is not supported by the specification as originally filed. The terms “major axis” and “transverse angle” are not recited in the specification. Although the drawings may appear to show a major axis at a slight transverse angle, the drawings alone cannot be relied upon as support.
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 16 is rejected under 35 U.S.C. 102(a)(1)/(2) as anticipated by U.S. Patent No. US 9,370,386 to Galm et al. (hereinafter, “Galm”).
As to claim 16, Galm discloses a bone plate (col. 7 / lines 30-67), FIG. 12, comprising: a shaft portion (940) including a first width; a head portion (portion surrounding 908) including a second width that is greater than the first width, wherein the shaft portion and the head portion together establish a bone plate structure that extends along a longitudinal axis (axis that longitudinally bisects the shaft portion in FIG. 12); a bone contacting surface fully capable of being configured to conform to a contour of a distal humerus of a non-human animal (interpreted as language of intended use and deemed anticipated by the prior art if capable of said intended use; the bone contacting surface is configured to conform to a contour of the bone to which the plate is applied, e.g. FIG. 4, and this bone is fully capable of being any bone including but not limited to a distal humerus of a non-human animal, with the dimensions of the plate made complementary); an outer surface opposed to the bone contacting surface; and the head portion is bounded by a peripheral (outer) edge that connects to a first side (left longitudinal outer side) and a second side (right longitudinal outer side) of the shaft portion, wherein the peripheral edge includes a curved expanded section (curved protruding corner on the upper left of the head portion) that connects to the first side of the shaft portion (via straight section extending at an angle along the left side of the head portion) and an outcropped section (curved protruding corner on the upper right of the head portion) that connects to the second side of the shaft portion (via straight section extending at an angle along the right side of the head portion), wherein the curved expanded section protrudes laterally outward in a first direction (to the left) from the longitudinal axis and terminates at a first (laterally) outermost location (the curved expanded section terminates laterally at a location on the peripheral edge on the upper left of the head portion, e.g. a laterally outermost location near where the curved protruding left corner meets the straight angled left section) of the peripheral edge that is a first distance from the longitudinal axis, and the outcropped section protrudes laterally outward in a second opposite direction (to the right) from the longitudinal axis and terminates (proximally) at a second (proximally) outermost location (the outcropped section terminates proximally at a location on the peripheral edge on the upper right of the head portion, e.g. a proximally outermost location furthest from the shaft portion) of the peripheral edge that is a second distance from the longitudinal axis, wherein the first distance and the second distance are lateral distances measured perpendicular to the longitudinal axis (the first distance is measured from the first laterally outermost location on the upper left to a point on the longitudinal axis along an axis perpendicular to the longitudinal axis, and the second distance is measured from the second proximally outermost location on the upper right to a point on the longitudinal axis along an axis perpendicular to the longitudinal axis), wherein the first distance is greater than the second distance.
Claims 16 and 20 are rejected under 35 U.S.C. 102(a)(1)/(2) as anticipated by U.S. Patent Application Publication No. US 2021/0338293 to Silva et al. (hereinafter, “Silva”).
As to claim 16, Silva discloses a bone plate, FIG. 4, comprising: a shaft portion (26, 28) including a first width (par. [0030]); a head portion (wider portion including 38 and 40) including a second width that is greater than the first width (par. [0031]), wherein the shaft portion and the head portion together establish a bone plate structure that extends along a longitudinal axis (A4; the bone plate structure extends along axis A4 at least at 28, and the rest of the bone plate structure also extends along axis A4 even if not bisected by such axis); a bone contacting surface configured to conform to a contour of a distal humerus of a non-human animal (interpreted as language of intended use and deemed anticipated by the prior art if capable of said intended use; the bone contacting surface is configured to conform to a contour of the bone to which the plate is applied, par. [0030], and this bone is fully capable of being any bone including but not limited to a distal humerus of a non-human animal, with the dimensions of the plate made complementary); an outer surface opposed to the bone contacting surface (par. [0030]); and the head portion is bounded by a peripheral (outer) edge that connects to a first side (right longitudinal outer side) and a second side (left longitudinal outer side) of the shaft portion, wherein the peripheral edge includes a curved expanded section (40) that connects to the first side of the shaft portion and an outcropped section (38) that connects to the second side of the shaft portion, wherein the curved expanded section protrudes laterally outward in a first direction (to the right) from the longitudinal axis and terminates at a first outermost location (a point on the peripheral edge of 40, e.g. a laterally outermost point) of the peripheral edge that is a first distance from the longitudinal axis (A4), and the outcropped section protrudes laterally outward in a second opposite direction (to the left) from the longitudinal axis and terminates at a second outermost location (a point on the peripheral edge of 38, e.g. a laterally outermost point) of the peripheral edge that is a second distance from the longitudinal axis (A4), wherein the first distance and the second distance are lateral distances measured perpendicular to the longitudinal axis (the first distance is measured from the laterally outermost point on the right outer edge of 40 perpendicularly relative and back to the longitudinal axis, and the second distance is measured from the point on the left outer edge of 38 on the left side of the longitudinal axis perpendicularly relative and back to the longitudinal axis), wherein the first distance is greater than the second distance (a laterally outermost point on the right side of 40 is further from A4 than a laterally outermost point on the left side of 38, which is shown in FIG. 4 to be immediately to the left of A4), FIG. 4.
As to claim 20, Silva discloses the bone plate as recited in claim 16, wherein the shaft portion includes a proximal tip section (28) that is angled relative to a distal straight section (distal section of 26) of the shaft portion (par. [0030]), FIG. 4.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 2, 4-6, 8, 9, 12, 14, 15, 17, 18, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Galm.
As to claim 1, Galm discloses a bone plate (col. 7 / lines 30-67), FIG. 12, designed for veterinary use (interpreted as language of intended use and deemed anticipated by the prior art if capable of said intended use; the bone plate is fully capable of being for veterinary use in a surgical application of fixing bone, as veterinarians treat various animals with long bones), comprising: a shaft portion (940); a head portion (portion surrounding 908); a bone contacting surface; an outer surface opposed to the bone contacting surface; and a hole (908) formed through the head portion and dimensioned to receive at least a portion of a condyle of a distal humerus of an animal such that, when the bone plate is positioned on the distal humerus, the condyle is received within the hole and the bone contacting surface seats against the distal humerus (interpreted as language of intended use and deemed anticipated by the prior art if capable of said intended use; the hole is fully capable of receiving at least a portion of a condyle of a distal humerus of an animal when the plate is applied to the distal humerus such that the hole extends over the condyle so that at least a portion of the condyle is received therein; the bone is fully capable of being any bone including but not limited to a distal humerus of an animal, with the dimensions of the plate made complementary and the hole specifically sized and shaped for the relevant application; the plate is fully capable of being positioned on any bone including the distal humerus, and the hole is fully capable of receiving at least a portion of the condyle when the plate is positioned on the distal humerus, such that the bone contacting surface seats against the bone as Galm discloses, in this case being the distal humerus).
As to claim 2, Galm discloses the bone plate as recited in claim 1, wherein the distal humerus is a canine distal humerus (interpreted as language of intended use, as above; the bone is fully capable of being any bone including but not limited to a canine distal humerus), and further wherein the bone contacting surface includes a curvature configured to match a contour, e.g. as seen in FIG. 4, of the canine distal humerus (interpreted as language of intended use, as above; the curvature would match the contour of the bone to which it is applied, which is fully capable of being the canine distal humerus).
As to claim 4, Galm discloses the bone plate as recited in claim 1, wherein the shaft portion includes a first length that is greater than a second length of the head portion, FIG. 12.
As to claim 5, Galm discloses the bone plate as recited in claim 1, wherein the head portion includes a first width that is greater than a second width of the shaft portion, FIG. 12.
As to claim 8, Galm discloses the bone plate as recited in claim 1, wherein the head portion is bounded by a peripheral (outer) edge that connects to a first side (left longitudinal outer side) and a second side (right longitudinal outer side) of the shaft portion.
As to claim 9, Galm discloses the bone plate as recited in claim 8, wherein the peripheral edge includes a curved expanded section (curved protruding corner on the upper left of the head portion) that connects to the first side of the shaft portion and an outcropped section (curved protruding corner on the upper right of the head portion) that connects to the second side of the shaft portion, and comprising a first opening (910 on the left, in the first upper row of 910’s) proximate the curved expanded section and a second opening (wire hole on right portion of the head portion) proximate the outcropped section (proximate the outcropped section because it is closer to the outcropped section than the curved expanded section), wherein the first opening includes a larger diameter than the second opening, FIG. 12.
As to claim 12, Galm discloses the bone plate as recited in claim 8, wherein the peripheral edge includes a curved expanded section (curved protruding corner on the upper left of the head portion) that connects to the first side of the shaft portion and a straight edge (straight right edge extending at an angle along the right side of the head portion) that connects to the second side of the shaft portion, FIG. 12, and comprising a first opening (910 on the left, in the second lower row of 910’s) proximate the curved expanded section (the first opening is proximate the curved expanded section because it is closer to the curved expanded section than the straight edge) and a second opening (910 on the right, in the second lower row of 910’s), a third opening (wire opening on the right of 908), and a fourth opening (910 on the right, in the first upper row of 910’s) proximate the straight edge.
As to claim 14, Galm discloses the bone plate as recited in claim 12, wherein the hole is positioned axially between the first opening and the second opening and the third opening, FIG. 12.
As to claim 15, Galm discloses the bone plate as recited in claim 1, wherein the head portion is angled at an inclined angle relative to the shaft portion, shown for example in FIGS. 3-4.
As to claim 27, Galm discloses the bone plate as recited in claim 1, wherein the hole is oriented such that a major axis of the hole extends in parallel with a longitudinal axis of the bone plate, FIG. 12.
Although Galm does not show the hole (908) is elliptical in FIG. 12, Galm does contemplate that the hole (window) may be elliptical (col. 9 / lines 45-48).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide the hole in an elliptical shape, since Galm contemplates that the window can be any of various shapes including elliptical, and an elliptical hole would provide certain viewing advantages or ease of manufacture. As shown in FIG. 12, the major axis of the hole, made to be elliptical as contemplated by Galm, would extend in parallel with a longitudinal axis of the bone plate.
As to claim 1, Galm discloses a bone plate (col. 6 / line 32 – col. 7 / line 29), FIG. 10, designed for veterinary use (interpreted as language of intended use and deemed anticipated by the prior art if capable of said intended use; the bone plate is fully capable of being for veterinary use in a surgical application of fixing bone, as veterinarians treat various animals with long bones), comprising: a shaft portion (740); a head portion (portion surrounding 708); a bone contacting surface; an outer surface opposed to the bone contacting surface; and a hole (708) formed through the head portion and dimensioned to receive at least a portion of a condyle of a distal humerus of an animal such that, when the bone plate is positioned on the distal humerus, the condyle is received within the hole and the bone contacting surface seats against the distal humerus (interpreted as language of intended use and deemed anticipated by the prior art if capable of said intended use; the hole is fully capable of receiving at least a portion of a condyle of a distal humerus of an animal when the plate is applied to the distal humerus such that the hole extends over the condyle so that at least a portion of the condyle is accommodated therein; the bone is fully capable of being any bone including but not limited to a distal humerus of an animal, with the dimensions of the plate made complementary and the hole specifically sized and shaped for the relevant application; the plate is fully capable of being positioned on any bone including the distal humerus, and the hole is fully capable of receiving at least a portion of the condyle when the plate is positioned on the distal humerus, such that the bone contacting surface seats against the bone as Galm discloses, in this case being the distal humerus).
As to claim 2, Galm discloses the bone plate as recited in claim 1, wherein the distal humerus is a canine distal humerus (interpreted as language of intended use, as above; the bone is fully capable of being any bone including but not limited to a canine distal humerus), and further wherein the bone contacting surface includes a curvature configured to match a contour, e.g. as seen in FIG. 4, of the canine distal humerus (interpreted as language of intended use, as above; the curvature would match the contour of the bone to which it is applied, which is fully capable of being the canine distal humerus).
As to claim 5, Galm discloses the bone plate as recited in claim 1, wherein the head portion includes a first width that is greater than a second width of the shaft portion, FIG. 10.
As to claim 6, Galm discloses the bone plate as recited in claim 1, comprising a plurality of openings (726 and 728; 710s) and at least one K-wire hole (716) formed through each of the shaft portion and the head portion, FIG. 10.
As to claim 8, Galm discloses the bone plate as recited in claim 1, wherein the head portion is bounded by a peripheral (outer) edge that connects to a first side (left longitudinal outer side) and a second side (right longitudinal outer side) of the shaft portion.
As to claim 9, Galm discloses the bone plate as recited in claim 8, wherein the peripheral edge includes a curved expanded section (curved protruding corner on the upper left of the head portion) that connects to the first side of the shaft portion and an outcropped section (curved protruding corner on the upper right of the head portion) that connects to the second side of the shaft portion, and comprising a first opening (710 on the left, in the first upper row of 710’s) proximate the curved expanded section and a second opening (wire hole on right portion of the head portion) proximate the outcropped section (proximate the outcropped section because it is closer to the outcropped section than the curved expanded section), wherein the first opening includes a larger diameter than the second opening, FIG. 10.
As to claim 12, Galm discloses the bone plate as recited in claim 8, wherein the peripheral edge includes a curved expanded section (curved protruding corner on the upper left of the head portion) that connects to the first side of the shaft portion and a straight edge (straight right edge extending at an angle along the right side of the head portion) that connects to the second side of the shaft portion, FIG. 10, and comprising a first opening (710 on the left, in the second lower row of 710’s) proximate the curved expanded section (the first opening is proximate the curved expanded section because it is closer to the curved expanded section than the straight edge) and a second opening (710 on the right, in the second lower row of 710’s), a third opening (wire opening on the right of 708), and a fourth opening (710 on the right, in the first upper row of 710’s) proximate the straight edge (closer to the straight edge than the curved expanded section).
As to claim 14, Galm discloses the bone plate as recited in claim 12, wherein the hole is positioned axially between the first opening and the second opening and the third opening, FIG. 10.
As to claim 15, Galm discloses the bone plate as recited in claim 1, wherein the head portion is angled at an inclined angle relative to the shaft portion, shown for example in FIGS. 3-4.
As to claim 27, Galm discloses the bone plate as recited in claim 1, wherein the hole is oriented such that a major axis of the hole extends in parallel with a longitudinal axis of the bone plate, FIG. 10.
Although Galm does not show the hole (708) is elliptical in FIG. 10, Galm does contemplate that the hole (window) may be elliptical (col. 9 / lines 45-48).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide the hole in an elliptical shape, since Galm contemplates that the window can be any of various shapes including elliptical, and an elliptical hole would provide certain viewing advantages or ease of manufacture. As shown in FIG. 10, the major axis of the hole, made to be elliptical as contemplated by Galm, would extend in parallel with a longitudinal axis of the bone plate.
As to claim 17, Galm discloses the bone plate as recited in claim 16, comprising a hole (908) formed through the head portion (col. 7 / lines 60-61) and fully capable of being configured for receiving a condyle of the distal humerus (interpreted as language of intended use and deemed anticipated by the prior art if capable of said intended use; the hole is fully capable of receiving a condyle of the distal humerus when the plate is applied to the distal humerus such that the hole extends over the condyle so that at least a portion of the condyle is received therein), wherein the distal humerus is a canine distal humerus (interpreted as language of intended use, as above; the bone is fully capable of being any bone including but not limited to a canine distal humerus).
As to claim 18, Galm discloses the bone plate as recited in claim 17, wherein the hole is positioned axially between a first opening (910 on the left, in the second lower row of 910’s) located proximate the curved expanded section (curved protruding corner on the upper left of the head portion; the first opening is proximate the curved expanded section because it is closer to the curved expanded section than the outcropped section) and a second opening (910 on the right, in the second lower row of 910’s) and a third opening (wire opening on the right of 908) formed proximate a straight section (straight side extending at an angle along the right side of the head portion) that connects to the outcropped section (curved protruding corner on the upper right of the head portion), FIG. 12, and further comprising a fourth opening (910 on the right, in the first upper row of 910’s) located proximate the outcropped section.
Although Galm does not show the hole (908) is elliptical in FIG. 12, Galm does contemplate that the hole (window) may be elliptical (col. 9 / lines 45-48).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide the hole in an elliptical shape, since Galm contemplates that the window can be any of various shapes including elliptical, and an elliptical hole would provide certain viewing advantages or ease of manufacture. As shown in FIG. 12, the major axis of the hole, made to be elliptical as contemplated by Galm, would extend in parallel with a longitudinal axis of the bone plate.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Galm in view of U.S. Patent No. US 10,864,026 to Wotton, III et al. (hereinafter, “Wotton”).
As to claim 3, Galm is silent as to comprising a relief formed in the bone contacting surface of the head portion.
As to claim 1, Wotton teaches a bone plate, FIG. 6, comprising a shaft portion; a head portion (42); a bone contacting surface (100); an outer surface opposed to the bone contacting surface.
As to claim 3, Wotton teaches the bone plate as recited in claim 1, comprising a relief (84) formed in the bone contacting surface of the head portion (col. 9 / lines 12-23), FIG. 6.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide a relief formed in the bone contacting surface of the head portion of Galm’s plate, as taught by Wotton, to provide a mark that provides an indication of a location of the plate over the bone to ensure proper placement with visual confirmation of the location of the mark relative to the bone.
Claims 21-23, 24-26, and 28-30 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. US 2005/0240187 to Huebner et al. (hereinafter, “Huebner”).
As to claim 21, Huebner discloses a bone plate, FIG. 7, designed for veterinary use (interpreted as language of intended use and deemed anticipated by the prior art if capable of said intended use; the bone plate is fully capable of being for veterinary use in a surgical application of fixing bone, as veterinarians treat various animals with long bones), comprising: a shaft portion (portion that is not widened, see annotated figure below); a head portion (widened portion) bounded by a peripheral (outer) edge that connects to a first side (right longitudinal outer side) and a second side (left longitudinal outer side) of the shaft portion, wherein the peripheral edge includes a curved expanded section (curved laterally protruding corner on the upper right of the head portion) that connects to the first side of the shaft portion and a straight section (see annotated figure) that connects to the second side of the shaft portion and extends in a direction parallel to a longitudinal axis of the bone plate (see annotated figure); a bone contacting surface; an outer surface opposed to the bone contacting surface, a hole (48) formed through the head portion and dimensioned to receive at least a portion of a condyle of a distal humerus of an animal when the bone plate is positioned on the distal humerus (interpreted as language of intended use and deemed anticipated by the prior art if capable of said intended use; the hole is fully capable of receiving at least a portion of a condyle of a distal humerus of an animal when the plate is applied to the distal humerus such that the hole extends over the condyle so that at least a portion of the condyle is received therein; the bone is fully capable of being any bone including but not limited to a distal humerus of an animal, with the dimensions of the plate made complementary); a first opening (152 on the right in the curved laterally protruding corner on the upper right) formed adjacent to the curved expanded section; and a second opening, a third opening, and a fourth opening (see annotated figure) formed adjacent to the straight section (where adjacent means next to; the second, third, and fourth openings are next to the straight section and not in the straight section, and closer to the straight section than to the shaft portion, for example), wherein the fourth opening is the proximal most opening of the head portion (where proximal is at the bottom of FIG. 7; an arbitrary reference scheme that could also be interpreted as most proximal/closest to the shaft portion) and is located closer to the shaft portion than the hole (48), FIG. 7.
As to claim 22, Huebner discloses the bone plate as recited in claim 21, wherein an entire length of the straight section extends in parallel with the longitudinal axis of the bone plate (see annotated figure).
As to claim 23, Huebner discloses the bone plate as recited in claim 22, wherein the longitudinal axis bisects the shaft portion into two equal sections and asymmetrically divides the head portion, and further wherein the longitudinal axis intersects through each of the second opening, the third opening, and the fourth opening (see annotated figure).
As to claim 25, Huebner discloses the bone plate as recited in claim 21, wherein each of the second opening, the third opening, and the fourth opening is located immediately adjacent to the straight section (where immediately adjacent is a relative term; the second, third, and fourth openings are each located immediately adjacent to the straight section because they are next to the section, and closer to the section than to the shaft portion).
As to claim 26, Huebner discloses the bone plate as recited in claim 21, wherein the hole is located axially between the first opening and the second opening and the third opening (the hole 48 near the top right straight edge is axially between the first opening and the second opening and the third opening because it is on an axis, parallel to the longitudinal axis, that is between the first opening and the second opening, and between the first opening and the third opening).
As to claim 28, Huebner discloses the bone plate as recited in claim 21, wherein a major axis of the hole (the hole 48 near the top right straight edge) extends at a transverse angle relative to the longitudinal axis of the bone plate (see annotated figure).
As to claim 30, Huebner discloses the bone plate as recited in claim 21, wherein the hole (the hole 48 near the top right straight edge) is positioned axially between the first opening and the second, third, and fourth openings (the hole is positioned axially between the first opening and the second, third, and fourth openings because it is on an axis, parallel to the longitudinal axis, that is between the first opening and the second, third, and fourth openings).
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Huebner, FIG. 7, annotated
Huebner does show in FIG. 7 that the hole (48) is elongate, but does not show the hole (48) is elliptical; however, Huebner does contemplate that elongate bone plate openings may be elliptical (par. [0030]).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide the elongate hole in an elliptical shape, since Huebner contemplates that an elongate hole (as shown in FIG. 7) can be elliptical (par. [0030]), and providing the hole in an elliptical shape would provide fewer stress points than other shapes and would not fray any sutures received therein.
As to claim 21, Huebner discloses, in a second interpretation, a bone plate, FIG. 7, designed for veterinary use (interpreted as language of intended use and deemed anticipated by the prior art if capable of said intended use; the bone plate is fully capable of being for veterinary use in a surgical application of fixing bone, as veterinarians treat various animals with long bones), comprising: a shaft portion (portion that is not widened, see annotated figure); a head portion (widened portion) bounded by a peripheral edge (outer edge/sidewall around the entire plate) that connects to a first side (bottom facing side/surface of the shaft portion; connected to the peripheral edge which extends between the first and second sides) and a second side (top facing side/surface of the shaft portion; connected to the peripheral edge which extends between the first and second sides) of the shaft portion, wherein the peripheral edge includes a curved expanded section (curved laterally protruding corner of the edge on the upper right of the head portion) that connects to the first side of the shaft portion (since the entire peripheral edge connects to the first side of the shaft portion) and a straight section (see annotated figure; the straight section is the section of the edge/sidewall that is at the lower, bottom side of the sidewall, i.e. the lower edge of the plate at the bone facing side where the sidewall meets the bone contacting surface) that connects to the second side of the shaft portion (since the entire peripheral edge connects to the second side of the shaft portion) and extends in a direction parallel to a longitudinal axis of the bone plate (see annotated figure); a bone contacting surface; an outer surface opposed to the bone contacting surface, a hole (48) formed through the head portion and dimensioned to receive at least a portion of a condyle of a distal humerus of an animal when the bone plate is positioned on the distal humerus (interpreted as language of intended use and deemed anticipated by the prior art if capable of said intended use; the hole is fully capable of receiving at least a portion of a condyle of a distal humerus of an animal when the plate is applied to the distal humerus such that the hole extends over the condyle so that at least a portion of the condyle is received therein; the bone is fully capable of being any bone including but not limited to a distal humerus of an animal, with the dimensions of the plate made complementary); a first opening (152 on the right in the curved laterally protruding corner on the upper right) formed adjacent to the curved expanded section; and a second opening, a third opening, and a fourth opening (see annotated figure) formed adjacent to the straight section (where adjacent means next to; the second, third, and fourth openings are next to the straight section and not in the straight section, and closer to the straight section than to the shaft portion, for example), wherein the fourth opening is the proximal most opening of the head portion (where proximal is at the bottom of FIG. 7; an arbitrary reference scheme that could also be interpreted as most proximal/closest to the shaft portion) and is located closer to the shaft portion than the hole (48), FIG. 7.
As to claim 24, Huebner discloses the bone plate as recited in claim 21, wherein the peripheral edge includes an outcropped section (section of the edge/sidewall that is at the upper side of the sidewall, i.e. the upper edge of the plate where the sidewall meets the outer surface; this section is outcropped, or protrudes out and away from the bone/bone contacting surface) located between the straight section (the section of the edge/sidewall that is at the lower, bottom side of the sidewall) and the second side (top facing side/surface of the shaft portion) of the shaft portion.
Huebner does show in FIG. 7 that the hole (48) is elongate, but does not show the hole (48) is elliptical; however, Huebner does contemplate that elongate bone plate openings may be elliptical (par. [0030]).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide the elongate hole in an elliptical shape, since Huebner contemplates that an elongate hole (as shown in FIG. 7) can be elliptical (par. [0030]), and providing the hole in an elliptical shape would provide fewer stress points than other shapes and would not fray any sutures received therein.
As to claim 21, Huebner discloses, in a third interpretation, a bone plate, FIG. 7, designed for veterinary use (interpreted as language of intended use and deemed anticipated by the prior art if capable of said intended use; the bone plate is fully capable of being for veterinary use in a surgical application of fixing bone, as veterinarians treat various animals with long bones), comprising: a shaft portion (portion that is not widened, see annotated figure); a head portion (widened portion) bounded by a peripheral (outer) edge that connects to a first side (right longitudinal outer side) and a second side (left longitudinal outer side) of the shaft portion, wherein the peripheral edge includes a curved expanded section (curved laterally protruding corner on the upper right of the head portion) that connects to the first side of the shaft portion and a straight section (see annotated figure) that connects to the second side of the shaft portion and extends in a direction parallel to a longitudinal axis of the bone plate (see annotated figure); a bone contacting surface; an outer surface opposed to the bone contacting surface, a hole (48) formed through the head portion and dimensioned to receive at least a portion of a condyle of a distal humerus of an animal when the bone plate is positioned on the distal humerus (interpreted as language of intended use and deemed anticipated by the prior art if capable of said intended use; the hole is fully capable of receiving at least a portion of a condyle of a distal humerus of an animal when the plate is applied to the distal humerus such that the hole extends over the condyle so that at least a portion of the condyle is received therein; the bone is fully capable of being any bone including but not limited to a distal humerus of an animal, with the dimensions of the plate made complementary); a first opening (152 on the right in the curved laterally protruding corner on the upper right) formed adjacent to the curved expanded section; and a second opening, a third opening, and a fourth opening (see annotated figure; the second and third openings are as labelled in the annotated figure above, and the fourth opening is the other hole 152 that is not on the longitudinal axis but to the upper right from the “fourth opening” labelled in the annotated figure) formed adjacent to the straight section (where adjacent means next to; the second, third, and fourth openings are next to the straight section and not in the straight section, and closer to the straight section than to the shaft portion, for example), wherein the fourth opening is the proximal most opening of the head portion (where proximal is at the bottom of FIG. 7; an arbitrary reference scheme that could also be interpreted as most proximal/closest to the shaft portion; in this interpretation, the head portion includes only the widened portion up to and including the fourth opening) and is located closer to the shaft portion than the hole (48), FIG. 7.
As to claim 29, Huebner discloses the bone plate as recited in claim 21, wherein each of the first opening, the second opening, the third opening, and the fourth opening extends at an angle relative to a transverse axis that extends vertically through the head portion and is perpendicular to the longitudinal axis of the bone plate, FIG. 8.
Huebner does show in FIG. 7 that the hole (48) is elongate, but does not show the hole (48) is elliptical; however, Huebner does contemplate that elongate bone plate openings may be elliptical (par. [0030]).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide the elongate hole in an elliptical shape, since Huebner contemplates that an elongate hole (as shown in FIG. 7) can be elliptical (par. [0030]), and providing the hole in an elliptical shape would provide fewer stress points than other shapes and would not fray any sutures received therein.
Huebner is silent as to the angle being about 10 degrees.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make the angle at which each of the first opening, the second opening, the third opening, and the fourth opening extends relative to the transverse axis about 10 degrees, since where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. An angle of about 10 degrees would prevent pullout of the fasteners from the bone and backout of the plate while also preventing the fasteners from interfering with each other.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TRACY L KAMIKAWA whose telephone number is (571)270-7276. The examiner can normally be reached M-F 10:00-6:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong, can be reached at 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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/TRACY L KAMIKAWA/Examiner, Art Unit 3775
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