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 .
Election/Restrictions
Applicant’s election of Invention I Species A (Claims 1-10) in the reply filed on 6/23/26 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 11-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention/species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/23/26.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-2, 6-10 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
In claim 1 at line 13-15 the limitation recites “first surface of the plate is shaped to contour to a portion of the surface of the humerus that extends along at least one of a distal epiphysis, a distal metaphysis, or a diaphysis of the humerus”.
In claim 2
at lines 2-3 the limitation recites “first openings spaced apart from one another longitudinally along a shaft portion of the plate that corresponds to at least one of the diaphysis or the distal metaphysis of the humerus”
at lines 5-6 the limitation recites “second openings spaced apart from one another along a distal portion of the plate that corresponds to at least one of the distal metaphysis or the distal epiphysis of the humerus,”
In claim 6
At lines 1-2 the limitation recites “ one of the second openings defines the nominal fastener insertion axis to target a capitellum of the humerus”
At lines 2-3 the limitation recites “ second openings each define the nominal fastener insertion axis to avoid an olecranon fossa of the humerus”
In claim 7 at lines 1-3 the limitation recites “ first surface of the plate is shaped to contour to a portion of the surface of the humerus that extends along a posterolateral side of a lateral epicondyle of the humerus”
In claim 8 at lines 5-6 the limitation recites “two of the second openings of the lateral extension plate are longitudinally spaced relative to each other and each define the nominal fastener insertion axis to target a medial epicondyle or a trochlea of the humerus”
In claim 9
At lines 1-2 the limitation recites “one of the second openings defines the nominal fastener insertion axis to target a lateral epicondyle or a medial epicondyle of the humerus”
At lines 3-4 the limitation recites “ one other of the second openings defines the nominal fastener insertion axis to target a trochlea of the humerus”
In claim 10 at lines 1-3 the limitation recites “ the first surface of the plate is shaped to contour to a portion of the surface of the humerus that extends along a medial epicondyle or a lateral epicondyle of the humerus”
These limitations cannot be satisfied without the inclusion of the human organism, or the parts of the humerus, therefore, applicant is claiming the humerus as part of the invention. Instead, applicant should use “adapted to” or “configured to” language to overcome the 101 rejection.
Claim Rejections - 35 USC § 103
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.
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) 1-3 and 5-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Laird, Jr et al (US Patent Pub. 20190269443A1) in view of Forstein et al (US Patent Pub. 20060173458A1).
Laird recites a plate configured to support a humerus (Fig. 1 and Para. [0062]). Specifically in regards to claim 1, the plate (102) extending longitudinally to define a proximal end and a distal end opposite the proximal end, the plate (102) comprising: a first surface (surface shown in Fig. 6) and a second surface opposite the first surface, wherein at least a portion of the first surface is configured to contact a surface of the humerus (Fig. 1-6; and Para. [0062],[0068]-[0069]). Openings (120/121/140) spaced apart from one another along the plate (102), each of the openings (120/121/140) defining a fastener insertion axis for a fastener to be inserted therethrough; and apertures (124/144) each adjacent to at least one of the openings (120/121/140), each of the apertures (124/144) defining a stabilizer insertion axis for a stabilizer (k-wires) to be inserted therethrough, wherein the stabilizer insertion axis is generally parallel with the fastener insertion axis of the at least one of the openings (120/121/140) to which each of the apertures (124/144) is adjacent (Fig. 3-4; and Para. [0071]-[0073],[0077]-[0078]). The first surface of the plate is shaped to contour to a portion of the surface of the humerus that extends along at least one of a distal epiphysis, a distal metaphysis, or a diaphysis of the humerus (The recitation of the plate contouring to the humerus along at least one of a distal epiphysis, a distal metaphysis, or a diaphysis of the humerus is being recited as an intended use recitation. 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. In the instant case, the reference recites wherein plate 102 fit one more long bones, such as a proximal humerus or a distal humerus.) (Para. [0062]). However, the reference is silent as to a beveled surface.
Forstein recites a plate configured to support a humerus (Fig. 1 and Para. [0066]). Specifically in regards to claim 1, the plate (50) recites wherein a second surface is beveled (76,78,86) at the proximal end (90) of the plate (50) to form a beveled portion (Fig. 1-2; and Para. [0069]-[0070]); and wherein at least one of the apertures (59) extends through the beveled portion (Fig. 1). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the second surface of the plate (102) of Laird to have a beveled portion as taught in Forstein so that the reduced thickness of the bone plate facilitates the positioning of the soft tissue over the bone plate after the bone plate has been placed in the body (Para. [0068]).
In regards to claim 2, Laird recites wherein the openings (140/120/121) comprise: first openings (140) spaced apart from one another longitudinally along a shaft portion of the plate (102) that corresponds to at least one of the diaphysis or the distal metaphysis of the humerus, each of the first openings (140) configured to receive a first fastener; and second openings (120/121) spaced apart from one another along a distal portion of the plate (102) that corresponds to at least one of the distal metaphysis or the distal epiphysis of the humerus, each of the second openings (120/121) configured to receive a second fastener, wherein a diameter of each of the first openings (140) is larger than a diameter of each of the second openings (120/121) (Fig. 3-4; and Para. [0081]).
In regards to claim 3, Laird recites wherein the fastener insertion axis of each of the first openings (140) and the second openings (120/121) each includes a nominal fastener insertion axis and a conical range of fastener insertion axes surrounding the nominal fastener insertion axis, and wherein the stabilizer insertion axis (axis of 124/144) of each of the apertures (124/144) is generally parallel with the nominal fastener insertion axis of the at least one of the first openings (140) or the second openings (120/121) to which each of the apertures is adjacent (Fig. 3-4; and Para. [0071],[0075]).
In regards to claim 5, Laird recites wherein at least some of the first openings (140) define the nominal fastener insertion axis to be substantially normal to the second surface of the plate (Fig. 4).
In regards to claim 6, Laird recites wherein at least one of the second openings (120/121) defines the nominal fastener insertion axis to target a capitellum of the humerus, and the second openings (120/121) each define the nominal fastener insertion axis to avoid an olecranon fossa of the humerus (The recitation of the fastener axes targeting a capitellum or avoiding an olecranon fossa of the humerus is being interpretated as an intended use recitation. 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. In the instant case, the reference recites wherein plate 102 fit one more long bones, such as a proximal humerus or a distal humerus.) (Fig. 1-4; and Para. [0062]).
In regards to claim 7, Laird recites wherein the first surface of the plate (102) is shaped to contour to a portion of the surface of the humerus that extends along a posterolateral side of a lateral epicondyle of the humerus (The recitation of the plate contouring to a surface that extends along a posterolateral side of a lateral epicondyle of the humerus is being interpretated as an intended use recitation. 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. In the instant case, the reference recites wherein plate 102 fit one more long bones, such as a proximal humerus or a distal humerus.) (Fig. 1-4; and Para. [0062]).
In regards to claim 8, Laird recites a lateral extension plate (portion of 102 with 104) that extends from the distal portion of the plate (102) in a lateral direction, the lateral extension plate including at least two of the second openings (120/121), wherein two of the second openings (120/121) of the lateral extension plate are longitudinally spaced relative to each other and each define the nominal fastener insertion axis to target a medial epicondyle or a trochlea of the humerus (The recitation of the fastener insertion axis to target a medial epicondyle or a trochlea of the humerus is being interpretated as an intended use recitation. 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. In the instant case, the reference recites wherein plate 102 fit one more long bones, such as a proximal humerus or a distal humerus.) (Fig. 1-4; and Para. [0062]).
In regards to claim 9, Laird recites wherein at least one of the second openings (120/121) defines the nominal fastener insertion axis to target a lateral epicondyle or a medial epicondyle of the humerus, and at least one other of the second openings (120/121) defines the nominal fastener insertion axis to target a trochlea of the humerus (The recitation of the fastener insertion axis to target to target a lateral epicondyle or a medial epicondyle or a trochlea of the humerus is being interpretated as an intended use recitation. 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. In the instant case, the reference recites wherein plate 102 fit one more long bones, such as a proximal humerus or a distal humerus.) (Fig. 1-4; and Para. [0062]).
In regards to claim 10, Laird recites wherein the first surface of the plate (102) is shaped to contour to a portion of the surface of the humerus that extends along a medial epicondyle or a lateral epicondyle of the humerus (The recitation of the plate contouring to a medial epicondyle or a lateral epicondyle of the humerus is being interpretated as an intended use recitation. 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. In the instant case, the reference recites wherein plate 102 fit one more long bones, such as a proximal humerus or a distal humerus.) (Fig. 1-4; and Para. [0062]).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Laird in view of Forstein as applied to claim 3 above, and further in view of Tiongson et al (US Patent Pub. 20190076175A1).
Laird in view of Forstein recite a plate configured to support a humerus comprising first and second surfaces, openings defining fastener insertion axes, apertures defining stabilizer insertion axes, and wherein the plate surface is shaped to contour the humerus and the second surface has a beveled portion. However, the references are silent as to the conical range of the fastener insertion axes.
Tiongson recites a plate configured to support a humerus (Fig. 1 and Para. [0066]). Specifically in regards to claim 4, the plate (200) recites wherein the conical range of fastener insertion axes defines a cone having an aperture angle of about 40 degrees (Fig. 4 and Para. [0049]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the openings of the plate (102) of Laird to have a conical range of 40 degrees as taught in Tiongson in order to accommodate several multi-planar diverging trajectories to allow a surgeon to select optimal screw trajectories to avoid any existing hardware in the condylar region (Para. [0049]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCELA I SHIRSAT whose telephone number is (571)270-5269. The examiner can normally be reached M-F 9:00am-5:30pm MST.
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MARCELA . SHIRSAT
Primary Examiner
Art Unit 3775
Prosecution Insights