Detailed Action
This is the final office action for US application number 18/969,046. Claims are evaluated as filed on August 14, 2026.
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 Arguments
Applicant's arguments filed August 14, 2026 have been fully considered but they are not persuasive. The rejections in this office action have been amended to address the amended claims. Examiner asserts that Lee, Briggs, Hoegerle, Judet, and Kim teach all the newly-amended limitations and are capable of performing the functions as claimed. Examiner directs Applicant to the rejection below for a more in-depth description of the limitations.
With regards to Applicant’s argument that no cited art features the amended scope of claim 1 and similar features for new claim 40 (Remarks p. 7), Examiner notes as an initial matter that none of the amended scope of claim 1 is provided in claim 1. That is, claim 1 has been amended to comprise “the primary barrel is further configured with a geometry to prevent rotation and includes a through hole for receiving a guidewire”; however, claim 40 does not recite a primary barrel or any features thereof. As to the amended scope of claim 1, Lee Fig. 4 clearly shows the primary hole 324, 321 as having sharp notches 324s and 344s as disclosed in ¶21, which are clearly capable of preventing rotation due to the generally triangular shape that would thereby prevent the primary fixation element from rotating therein. Further, Lee Fig. 4 clearly shows the primary hole 324, 321 for receiving primary fixation element 44, which ¶s 20 and 21 disclose is followed by additional screw 36 after 44 is removed and therefore such is capable of receiving a guidewire when 44 and 36 are not inserted therein, i.e. as claimed. Further, Briggs teaches adding the a slotted primary barrel (Fig. 7, col. 4 lines 40-46 discloses that the space between ribs 26/27 is adapted for the primary fixation element) capable of matching an outer morphology of the primary fixation element (Figs. 3, 5, 7, and 8), where the primary barrel is further configured with a geometry (Fig. 7) capable of preventing rotation (due to the slots/ribs 26/27, Fig. 7, col. 4 lines 40-46) and includes a through hole (Fig. 7) capable of receiving a guidewire (col. 4 lines 40-46 discloses that the space between ribs 26/27 is adapted for the primary fixation element, therefore, such is capable of receiving a guidewire when 16 is not inserted therein). Thus, the primary barrel of the combination of Lee and Briggs reads on the amended scope of claim 1.
With regards to Applicant’s argument that none of the cited art provides wings that extend radially outward as provided by claims 41-43 (Remarks p. 8), Examiner directs Applicant to the teaching of Kim as provided in the rejections below, where Fig. 3 shows that 14 and complementarily shaped right end of 20 provide two such wings.
Claim Objections
Claim(s) 1 is/are objected to because of the following informalities:
Claim 1 lines 12-13 should read “wherein a primary barrel of the plurality of cannulated barrels is configured to receive the primary fixation element, wherein the primary barrel is of a larger diameter”.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a primary fixation element” in claim 1 line 2, “a primary fixation element” in claim 40 line 2, “at least one supplemental fixation element” in claim 40 lines 2-3, and “at least one positioning fixation element” in claim 40 line 3.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 1, 3, 5, 7, 10-12,15-17, 19, 23, and 41-43 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim(s) 1 is/are unclear with regards to “the primary barrel … includes a through hole for receiving a guidewire” in lines 19-20 and how it can be reasonably construed that a through hole is defined within the primary barrel of the plurality of cannulated barrels, i.e. a hole is defined within a cannula/hole has been claimed. Examiner is interpreting this broadly and suggests amending to clarify.
Claim(s) 41 is/are unclear with regards to “the primary fixation element … configured to allow translation of the elongate shaft through one of the at least one hole” in lines 4-5 for the at least one hole that is configured to receive the positioning fixation element of claim 40 lines 5-6. There appears to be no reasonable grounds for asserting that the holes 206 that are configured to receive the positioning elements 208 are also capable of receiving the primary fixation element 214 as 214 is shown to be considerably larger and differently shaped as shown in Fig. 2C. Examiner is interpreting this as referring to, and suggests amending as, “wherein the primary fixation element includes: an elongate shaft having the through hole; a wing extending radially away from the elongate shaft and configured to allow translation of the elongate shaft through a primary hole, but prevent rotation of the elongate shaft relative to the plate.”
Claim(s) 42 recites/recite the limitation "the length” in line 4. There is insufficient antecedent basis for this limitation in the claim. Examiner is interpreting this as referring to, and suggests amending as, “[[the]]a length”.
Claim(s) 42 is/are unclear with regards to “the primary fixation element … configured to allow translation of the elongate shaft through one of the at least one hole” in lines 4-5 for the at least one hole that is configured to receive the positioning fixation element of claim 40 lines 6-7. There appears to be no reasonable grounds for asserting that the holes 206 that are configured to receive the positioning elements 208 are also capable of receiving the primary fixation element 214 as 214 is shown to be considerably larger and differently shaped as shown in Fig. 2C. Examiner is interpreting this as referring to, and suggests amending as, “wherein the primary fixation element includes: an elongate shaft having the through hole; a wing extending radially away from the elongate shaft and configured to allow translation of the elongate shaft through a primary hole, but prevent rotation of the elongate shaft relative to the plate.”
Claim(s) 43 recites/recite the limitation "the length” in line 4. There is insufficient antecedent basis for this limitation in the claim. Examiner is interpreting this as referring to, and suggests amending as, “[[the]]a length”.
Claim(s) 3, 5, 7, 10-12, 15-17, 19, and 23 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for its/their dependence on one or more rejected base claims.
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 of this title, 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, 5, 7, 10-12, 15, 19, and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (US 2013/0096630, hereinafter “Lee”) in view of Briggs (US 2,621,653) and Hoegerle et al. (US 2008/0119855, hereinafter Hoegerle”).
As to claim 1, Lee discloses a device (30, Fig. 4) capable of bone fracture fixation (¶s 8 and 21 discloses bone fracture fixation) comprising: a plate (32), a primary fixation element (44), at least one supplemental screw (upper 36s as shown in Fig. 4, Fig. 4, ¶21), and at least one positioning screw (lower 36s as shown in Fig. 4, Fig. 4, ¶21); wherein the plate tapers at an end (Fig. 4) and is further configured with at least one hole (321s) capable of receiving the at least one positioning screw (Fig. 4, ¶21); and wherein the plate is capable of conforming to a bone for fixation (Fig. 4, ¶16, 17, 20, and 21, i.e. shown in Fig. 2 for an alternate embodiment), capable of insertion without open exposure of a fracture site (in as much as Applicant’s, Fig. 4), and capable of receiving the primary fixation element and the at least one supplemental screw (Fig. 4, ¶21), wherein the plate comprises at least two threaded supplemental holes (321s/121s for 36s/16s shown having threads in Fig. 4, e.g. “first inner threads 122” of ¶18, Fig. 4, ¶s 18 and 20; where ¶20 discloses substantial similarity to the first embodiment, i.e. of Figs. 1-3) capable of receiving the at least one supplemental screw (Figs. 3 and 4, ¶s 18 and 20), the plate further comprising a primary hole (324, 321, Fig. 4) capable of receiving the primary fixation element (Fig. 4, ¶21), wherein the primary hole is inserted is of a larger diameter (Fig. 4) and positioned more centrally than the at least two threaded supplemental holes (Fig. 4), and wherein the primary hole is slotted (324s, Fig. 4, ¶21; where ¶21 discloses that 324s and 344s are sharp notches, where slotted has been interpreted as “a narrow opening or groove : slit, notch” (https://www.merriam-webster.com/dictionary/slotted) capable of matching an outer morphology of the primary fixation element (Fig. 4, ¶s 20 and 21) such that the primary fixation element is capable of translating freely along the axis of the primary hole without angulation or rotation (Fig. 4, ¶s 20 and 21); wherein the primary fixation element is capable of engaging a corresponding plate hole on an opposing side of bone (341, 344, Fig. 4, ¶s 20 and 21), wherein the primary hole is further configured with a geometry (Fig. 4) capable of preventing rotation (due to the slots/notches 324s of the triangular shape, Figs. 3 and 4, ¶s 20 and 21) and includes a through hole (Fig. 4) capable of receiving a guidewire (¶s 20 and 21 disclose that the primary hole receives primary fixation element 44 followed by additional screw 36 after 44 is removed, therefore, such is capable of receiving a guidewire when 44 and 36 are not inserted therein). As to claim 3, Lee discloses that the bone that the plate is capable of conforming to is a calcar of a femur (Fig. 4, ¶8) and the device is further capable of affixing in a pertrochanteric region (Fig. 4, ¶8). As to claim 5, Lee discloses that the primary fixation element is capable of terminating within a distance to an end of the bone (Fig. 4, ¶21). As to claim 7, Lee discloses that the primary fixation element is capable of preventing rotation (due to the triangular shape, Fig. 4, ¶21). As to claim 10, Lee discloses that the device is capable of being positioned proximal to a calcar (Fig. 4, ¶8). As to claim 11, Lee discloses that the device is further capable of preventing caudal displacement of a femoral head and femoral neck after insertion of the primary fixation element (Fig. 4, ¶8). As to claim 12, Lee discloses that at least one of the at least one supplemental screws and the at least one positioning screws comprises a locking or nonlocking bone screw (as defined, Fig. 4, ¶21). As to claim 15, Lee discloses that the at least one supplemental screw are further capable of being angulated to be positioned capable of fixation across a fracture (Fig. 4). As to claim 19, Lee discloses that the device is configured so that a fracture cannot compress more than a set distance once the device is affixed (due to the screws connecting to both plate 32 and plate 34 as disclosed in ¶21, Fig. 4, ¶21). As to claim 23, Lee discloses that the primary fixation element is capable of coupling to a jig (due to the shape of 441, Fig. 4) capable of use for alignment and insertion (if one so chooses to use such a jig, Fig. 4).
Lee is silent to the primary hole and the at least two threaded supplemental holes configured with a plurality of cannulated barrels that extend distally and the plurality of cannulated barrels are configured to receive the primary fixation element and the at least one supplemental screw. As to claim 10, Lee is silent to the primary barrel is further configured to be angulated. As to claim 15, Lee is silent to the at least two supplementary barrels are further configured to be angulated so that the at least one supplemental fixation screw is positioned for fixation across a fracture.
Briggs teaches a similar device (Figs. 3, 5, 7, and 8) capable of bone fracture fixation (Fig. 3, col. 3lines 39-43 and 59-61) comprising: a plate (19), a primary fixation element (16), at least one supplemental screw (upper 21s as shown in Fig. 3, Fig. 3), and at least one positioning screw (lower 21s as shown in Fig. 3, Fig. 3); wherein the plate is further configured with at least one hole (20s) capable of receiving the at least one positioning screw (Fig. 3); wherein the plate is capable of conforming to a bone for fixation (col. 3 lines 21-22), capable of insertion without open exposure of a fracture site (in as much as Applicant’s, Fig. 3), and capable of receiving the primary fixation element and the at least one supplemental screw (Fig. 3); wherein the plate is further configured with a cannulated barrel (17) that extends distally (Fig. 3) and the cannulated barrel is capable of receiving the primary fixation element (Fig. 3); and the cannulated barrel is a primary barrel (Fig. 3) that is capable of receiving the primary fixation element (Fig. 3), wherein the primary barrel is inserted is of a larger diameter than at least two of positioning screws (Figs. 3, 5, 7, and 8), and wherein the primary barrel is slotted (Fig. 7, col. 4 lines 40-46 discloses that the space between ribs 26/27 is adapted for the primary fixation element) capable of matching an outer morphology of the primary fixation element (Figs. 3, 5, 7, and 8) such that the primary fixation element is capable of translating freely along the axis of the primary barrel without angulation or rotation (Figs. 3, 5, 7, and 8). wherein the primary barrel is further configured with a geometry (Fig. 7) capable of preventing rotation (due to the slots/ribs 26/27, Fig. 7, col. 4 lines 42-57) and includes a through hole (Fig. 7) capable of receiving a guidewire (col. 4 lines 40-46 discloses that the space between ribs 26/27 is adapted for the primary fixation element, therefore, such is capable of receiving a guidewire when 16 is not inserted therein). As to claim 10, Briggs teaches that the primary barrel is further capable of being angulated (Fig. 3, col. 3 lines 60-65) and positioned proximal to a calcar (Fig. 3). As to claim 11, Briggs teaches that the primary barrel is further capable of preventing caudal displacement of a femoral head and femoral neck after insertion of the primary fixation element (Fig. 3).
Hoegerle teaches a similar device (Figs. 1-3) capable of bone fracture fixation (Fig. 1) comprising: a plate (3), a primary fixation element (7 of the lower right 5 as shown in Fig. 2, Fig. 2, ¶22), at least one supplemental screw (7s, Figs. 1-3, ¶22), and at least one positioning screw (4s, Fig. 1, ¶22); wherein the plate tapers at an end (Fig. 2) and is further configured with at least one hole (Figs. 1 and 2, ¶30) capable of receiving the at least one positioning screw (Figs. 1 and 2, ¶30); wherein the plate is capable of conforming to a bone for fixation (Fig. 1), capable of insertion without open exposure of a fracture site (in as much as Applicant’s, Fig. 1), and capable of receiving the primary fixation element and the at least one supplemental screw (Fig. 1); wherein the plate is further configured with a plurality of cannulated barrels (6s, Figs. 1 and 2, ¶s 22 and 23) that extend distally (Fig. 1) and the plurality of cannulated barrels are capable of receiving the primary fixation element (Figs. 1 and 2, ¶s 22 and 23) and the at least one supplemental screw (Figs. 1 and 2, ¶s 22 and 23); and a primary barrel of the plurality of cannulated barrels (Fig. 1, ¶s 22 and 23) capable of receiving the primary fixation element (Fig. 1, ¶s 22 and 23), wherein the primary barrel is positioned more centrally than at least two of the plurality of cannulated barrels (as defined, Figs. 1 and 2); wherein the plate comprises at least two threaded supplemental holes (upper 5s and lower left 5 as shown in Fig. 2, Fig. 2, ¶22) capable of receiving the at least one supplemental screw (Figs. 1 and 2, ¶s 22 and 23), the plate further comprising a primary hole (324, 321, Fig. 4) capable of receiving the primary fixation element (lower right 5 as shown in Fig. 2, Fig. 2, ¶22). As to claim 15, Hoegerle teaches that the at least two supplementary barrels are further capable of being angulated (Figs. 1 and 2) so that the at least one supplemental fixation screw is positioned for fixation across a fracture (Fig. 1). As to claim 19, Hoegerle teaches that that the device is configured so that a fracture cannot compress more than a set distance once the device is affixed (due annular step 11 and thread 15 as disclosed in ¶25, Figs. 1 and 2, ¶25).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the plate portion of the primary hole as disclosed by Lee by adding a primary barrel configured to receive the primary fixation element as taught by Briggs in order to enclose a portion of the primary fixation element (col. 3 lines 6-10), effect a strong gripping action (col. 4 lines 13-16), and prevent rotation of a proximal bone fragment (col. 4 lines 42-57) to aid in accurate alignment of the primary hole and a corresponding plate hole on an opposing side of bone (Lee Fig. 4, ¶20 and 21). One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the at least two threaded supplemental holes as disclosed by Lee with by adding a plurality of cannulated barrels configured to receive the at least one supplemental screw as taught by Hoegerle in order to secure two bone fragments relative to one another (¶s 30 and 31) while permitting a first bone fragment to be moved slightly in the direction towards a second bone fragment when the bone is stressed so that growth of the bone can be stimulated as a result of this slight movement and the additional stressing connected therewith in the contact area of the two bone fragments (Hoegerle ¶31).
Claim(s) 16 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee, Briggs, and Hoegerle in view of Judet et al. (US 5,591,168, hereinafter “Judet”).
As to claim 16, the combination of Lee, Briggs, and Hoegerle discloses invention of claim 1 as well as the tapered end of the plate is capable of being contoured to match the bone (Figs. 2-4, ¶20 discloses substantially similar construction with the first embodiment of Figs. 1-3).
The combination of Lee, Briggs, and Hoegerle is silent to the plate is malleable, the plate is silent to material properties of the plate.
Judet teaches a similar device (Figs. 1-5) capable of bone fracture fixation (Fig. 3, abstract) comprising: a plate (1a), a primary fixation element (lower 3 as shown in Fig. 3, Fig. 3), at least one supplemental screw (upper 3 as shown in Fig. 3, Fig. 3), and at least one positioning screw (“screw” of col. 3 line 9 for positioning within 1b as shown in Fig. 3, Fig. 3, col. 2 lines 3-4, col. 3 lines 7-10); wherein the plate tapers at an end (Fig. 3) and is further configured with at least one hole (1bs) capable of receiving the at least one positioning screw (Fig. 3, col. 2 lines 3-4, col. 3 lines 7-10); and wherein the plate is capable of conforming to a bone for fixation (Fig. 3, col. 2 lines 5-8), capable of use for insertion without open exposure of a fracture site (in as much as Applicant’s, Fig. 3), and capable of receiving the primary fixation element and the at least one supplemental screw (Fig. 3); wherein the plate is further configured with a plurality of cannulated barrels (1ds, Figs. 1-3, col. 2 lines 9-11) that extend distally (Figs. 1-3) and the plurality of cannulated barrels are capable of receiving the primary fixation element and the at least one supplemental screw (Fig. 3), wherein the primary barrel is positioned more centrally than at least one of the plurality of cannulated barrels (as defined, Fig. 3); wherein the bone that the plate is capable of conforming to is a calcar of a femur (Fig. 3) and the device is further capable of affixing in a pertrochanteric region (Fig. 3); the primary fixation element is capable of terminating within a distance to an end of the bone (Fig. 3); the plurality of cannulated barrels is capable of receiving the primary fixation element (Fig. 3) and is further capable of being angulated and positioned proximal to a calcar (Fig. 3); the plurality of cannulated barrels capable of receiving the supplemental screw (Fig. 3) and is further capable of being angulated so that the supplemental fixation screw is positioned capable of fixation across a fracture (Fig. 3); wherein the plate is malleable (col. 3 lines 20-22 disclose construction of stainless steel or any other bio-compatible material performing a perfect function and safety) and the tapered end of the plate is capable of being contoured to match the bone (Fig. 3, col. 3 lines 20-22).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to specify the material of the plate as disclosed by the combination of Lee, Briggs, and Hoegerle to be malleable as taught by Judet in order to select a known material construction of stainless steel or any other bio-compatible material performing a perfect function and safety (Judet col. 3 lines 20-22) so that appropriate plate portions are correctly located on the bone epiphysis (Lee Figs. 2-4, ¶s 16 and 20; where ¶20 discloses substantially similar construction with the first embodiment of Figs. 1-3).
As to claim 17, the combination of Lee, Briggs, and Hoegerle discloses invention of claim 1 as well as the plate is capable of angulation of the plurality of cannulated barrels (Lee Figs. 2-4, ¶20 discloses substantially similar construction with the first embodiment of Figs. 1-3; Briggs Figs. 3; Hoegerle Figs. 1 and 2).
The combination of Lee, Briggs, and Hoegerle is silent to the plate is malleable, the plate is silent to material properties of the plate.
Judet teaches a similar device (Figs. 1-5) capable of bone fracture fixation (Fig. 3, abstract) comprising: a plate (1a), a primary fixation element (lower 3 as shown in Fig. 3, Fig. 3), at least one supplemental screw (upper 3 as shown in Fig. 3, Fig. 3), and at least one positioning screw (“screw” of col. 3 line 9 for positioning within 1b as shown in Fig. 3, Fig. 3, col. 2 lines 3-4, col. 3 lines 7-10); wherein the plate tapers at an end (Fig. 3) and is further configured with at least one hole (1bs) capable of receiving the at least one positioning screw (Fig. 3, col. 2 lines 3-4, col. 3 lines 7-10); and wherein the plate is capable of conforming to a bone for fixation (Fig. 3, col. 2 lines 5-8), capable of use for insertion without open exposure of a fracture site (in as much as Applicant’s, Fig. 3), and capable of receiving the primary fixation element and the at least one supplemental screw (Fig. 3); wherein the plate is further configured with a plurality of cannulated barrels (1ds, Figs. 1-3, col. 2 lines 9-11) that extend distally (Figs. 1-3) and the plurality of cannulated barrels are capable of receiving the primary fixation element and the at least one supplemental screw (Fig. 3), wherein the primary barrel is positioned more centrally than at least one of the plurality of cannulated barrels (as defined, Fig. 3); wherein the bone that the plate is capable of conforming to is a calcar of a femur (Fig. 3) and the device is further capable of affixing in a pertrochanteric region (Fig. 3); the primary fixation element is capable of terminating within a distance to an end of the bone (Fig. 3); the plurality of cannulated barrels is capable of receiving the primary fixation element (Fig. 3) and is further capable of being angulated and positioned proximal to a calcar (Fig. 3); the plurality of cannulated barrels capable of receiving the supplemental screw (Fig. 3) and is further capable of being angulated so that the supplemental fixation screw is positioned capable of fixation across a fracture (Fig. 3); wherein the plate is malleable (col. 3 lines 20-22 disclose construction of stainless steel or any other bio-compatible material performing a perfect function and safety) and capable of angulation of the plurality of cannulated barrels (Fig. 3).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to specify the material of the plate as disclosed by the combination of Lee, Briggs, and Hoegerle to be malleable as taught by Judet in order to select a known material construction of stainless steel or any other bio-compatible material performing a perfect function and safety (Judet col. 3 lines 20-22) so that appropriate plate portions are correctly located on the bone epiphysis (Lee Figs. 2-4, ¶s 16 and 20; where ¶20 discloses substantially similar construction with the first embodiment of Figs. 1-3).
Claim(s) 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of Frigg et al. (US 6,187,007, hereinafter “Frigg”).
As to claim 40, Lee discloses a device (30, Fig. 4) capable of femur fracture fixation (¶s 8 and 21 discloses bone fracture fixation of a long bone) comprising: a plate (32) capable of being disposed over the femur (¶s 8 and 21 discloses bone fracture fixation of a long bone), a primary fixation element (44), at least one supplemental fixation element (upper 36s as shown in Fig. 4, Fig. 4, ¶21), and at least one positioning fixation element (lower 36s as shown in Fig. 4, Fig. 4, ¶21); wherein the plate tapers at an end (Fig. 4) and is further configured with at least one hole (321s) capable of receiving the at least one positioning fixation element (Fig. 4, ¶21); and wherein the plate is capable of conforming to the femur for fixation (Fig. 4, ¶16, 17, 20, and 21, i.e. shown in Fig. 2 for an alternate embodiment; where ¶s 8 and 21 disclose bone fracture fixation of a long bone), capable of insertion without open exposure of a fracture site (in as much as Applicant’s, Fig. 4), and capable of receiving the primary fixation element and the at least one supplemental fixation element (Fig. 4, ¶21).
Lee is silent to a guidewire and the primary fixation element having a through hole for receiving the guidewire for fixation assistance.
Frigg teaches a similar device (Figs. 1-3) capable of use for femur fracture fixation (Fig. 2) the device comprising: a plate (2) capable of being disposed over the femur (Fig. 2), a guidewire (col. 1 line 37, col. 2 lines 46-47), a primary fixation element (10) having a through hole (15) capable of receiving the guidewire (Fig. 2, col. 1 line 37, col. 2 lines 46-47) capable of fixation assistance (Fig. 2, col. 1 line 37, col. 2 lines 46-47).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the device and primary fixation element as disclosed by Lee by adding a guidewire and corresponding throughhole to the primary fixation as taught by Frigg in order to provide known structures for fracture fixation (Frigg Fig. 2; Lee ¶s 8 and 21) to aid in achieving desirable positioning.
Claim(s) 41-43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee and Frigg in view of Kim et al. (US 2011/0118741, hereinafter “Kim”).
As to claim 41, the combination of Lee and Frigg discloses the invention of claim 40 as well as the primary fixation element includes: an elongate shaft (Lee Fig. 4) having the through hole (Lee Fig. 4; Frigg Fig. 2); the primary fixation element capable of allowing translation of the elongate shaft through a primary hole (Lee 324, 321, Fig. 4), but prevent rotation of the elongate shaft relative to the plate (due to the shown complimentary shapes, Lee Fig. 4).
The combination of Lee and Frigg is silent to a wing extending radially away from the elongate shaft.
Kim teaches a device (Figs. 3 and 4) capable of use in femur fracture fixation (Fig. 4, ¶s 14, 26, and 27), the device comprising: a plate (see illustration of Fig. 3, Figs. 3 and 4) capable of being disposed over the femur (Figs. 3 and 4), a primary fixation element (20) having a through hole (see illustration of Fig. 3, Figs. 3 and 4), wherein the plate is configured with a primary hole (14) to receive the primary fixation element (Fig. 3, abstract); and wherein the plate is capable of conforming to the femur (Fig. 4) capable of fixation (Fig. 4), capable of use for insertion without open exposure of a fracture site (in as much as Applicant’s, Fig. 4), and to receive the primary fixation element (Fig. 4); wherein the primary fixation element includes: an elongate shaft (Fig. 3) having the through hole (as defined, Fig. 3); a wing (see illustration of Fig. 3, Fig. 3) extending radially away from the elongate shaft (Fig. 3) and capable of allowing translation of the elongate shaft through a primary hole (14, Fig. 3, abstract), but preventing rotation of the elongate shaft relative to the plate (due to the shown complimentary shapes, Fig. 3).
It would have been an obvious matter of design choice to one skilled in the art before the effective filing date of the claimed invention to modify the shape of the primary fixation element and corresponding plate hole of the combination of Lee and Frigg with the winged shape as taught by Kim, since Applicant has not disclosed that such is anything more than one of numerous shapes or configurations a person ordinary skill in the art would find obvious for the purpose of providing a known shape for a fracture repositioning (Fig. 3, ¶7) for engaging a primary fixation element with a plate (Fig. 3, ¶39).
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As to claim 42, the combination of Lee and Frigg discloses the invention of claim 40 as well as the primary fixation element includes: an elongate shaft (Lee Fig. 4) having the through hole (Lee Fig. 4; Frigg Fig. 2); the primary fixation element capable of allowing translation of the elongate shaft through a primary hole (Lee 324, 321, Fig. 4), but prevent rotation of the elongate shaft relative to the plate (due to the shown complimentary shapes, Lee Fig. 4).
The combination of Lee and Frigg is silent to a wing extending along the length of the elongate shaft and extending radially away from the elongate shaft and then laterally in a first lateral direction.
Kim teaches a device (Figs. 3 and 4) capable of use in femur fracture fixation (Fig. 4, ¶s 14, 26, and 27), the device comprising: a plate (see illustration of Fig. 3, Figs. 3 and 4) capable of being disposed over the femur (Figs. 3 and 4), a primary fixation element (20) having a through hole (see illustration of Fig. 3, Figs. 3 and 4), wherein the plate is configured with a primary hole (14) to receive the primary fixation element (Fig. 3, abstract); and wherein the plate is capable of conforming to the femur (Fig. 4) capable of fixation (Fig. 4), capable of use for insertion without open exposure of a fracture site (in as much as Applicant’s, Fig. 4), and to receive the primary fixation element (Fig. 4); wherein the primary fixation element includes: an elongate shaft (Fig. 3) having the through hole (as defined, Fig. 3); a wing (see illustration of Fig. 3, Fig. 3) extending along a length of the elongate shaft (along the length of 15a as shown in Fig. 3, Fig. 3) and extending radially away from the elongate shaft (Fig. 3) and then laterally in a first lateral direction (Fig. 3); wherein the wing is capable of allowing translation of the elongate shaft through a primary hole (14, Fig. 3, abstract), but preventing rotation of the elongate shaft relative to the plate (due to the shown complimentary shapes, Fig. 3).
It would have been an obvious matter of design choice to one skilled in the art before the effective filing date of the claimed invention to modify the shape of the primary fixation element and corresponding plate hole of the combination of Lee and Frigg with the winged shape as taught by Kim, since Applicant has not disclosed that such is anything more than one of numerous shapes or configurations a person ordinary skill in the art would find obvious for the purpose of providing a known shape for a fracture repositioning (Fig. 3, ¶7) for engaging a primary fixation element with a plate (Fig. 3, ¶39).
As to claim 43, the combination of Lee and Frigg discloses the invention of claim 40 as well as the primary fixation element includes: an elongate shaft (Lee Fig. 4) having the through hole (Lee Fig. 4; Frigg Fig. 2); the primary fixation element capable of allowing translation of the elongate shaft through a primary hole (Lee 324, 321, Fig. 4), but prevent rotation of the elongate shaft relative to the plate (due to the shown complimentary shapes, Lee Fig. 4).
The combination of Lee and Frigg is silent to a first wing extending along the length of the elongate shaft and extending radially away from the elongate shaft and then laterally in a first lateral direction; and a second wing extending along the length of the elongate shaft and extending radially away from the elongate shaft and then laterally in a second lateral direction opposite to the first lateral direction.
Kim teaches a device (Figs. 3 and 4) capable of use in femur fracture fixation (Fig. 4, ¶s 14, 26, and 27), the device comprising: a plate (see illustration of Fig. 3, Figs. 3 and 4) capable of being disposed over the femur (Figs. 3 and 4), a primary fixation element (20) having a through hole (see illustration of Fig. 3, Figs. 3 and 4), wherein the plate is configured with a primary hole (14) to receive the primary fixation element (Fig. 3, abstract); and wherein the plate is capable of conforming to the femur (Fig. 4) capable of fixation (Fig. 4), capable of use for insertion without open exposure of a fracture site (in as much as Applicant’s, Fig. 4), and to receive the primary fixation element (Fig. 4); wherein the primary fixation element includes: an elongate shaft (Fig. 3) having the through hole (as defined, Fig. 3); a first wing (see upper “Wing” as annotated on the illustration of Fig. 3, Fig. 3) extending along a length of the elongate shaft (along the length of 15a as shown in Fig. 3, Fig. 3) and extending radially away from the elongate shaft (Fig. 3) and then laterally in a first lateral direction (Fig. 3); a second wing (see lower “Wing” as annotated on the illustration of Fig. 3, Fig. 3) extending along the length of the elongate shaft (along the length of 15a as shown in Fig. 3, Fig. 3) and extending radially away from the elongate shaft (Fig. 3) and then laterally in a second lateral direction (Fig. 3) opposite to the first lateral direction (Fig. 3); wherein the first and second wings are capable of allowing translation of the elongate shaft through a primary hole (14, Fig. 3, abstract), but preventing rotation of the elongate shaft relative to the plate (due to the shown complimentary shapes, Fig. 3).
It would have been an obvious matter of design choice to one skilled in the art before the effective filing date of the claimed invention to modify the shape of the primary fixation element and corresponding plate hole of the combination of Lee and Frigg with the winged shape as taught by Kim, since Applicant has not disclosed that such is anything more than one of numerous shapes or configurations a person ordinary skill in the art would find obvious for the purpose of providing a known shape for a fracture repositioning (Fig. 3, ¶7) for engaging a primary fixation element with a plate (Fig. 3, ¶39).
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY SIPP whose telephone number is (313)446-6553. The examiner can normally be reached on Monday through Thursday, 6:30am-4pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong can be reached on 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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/AMY R SIPP/Primary Examiner, Art Unit 3775
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