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 .
Allowable Subject Matter
Claims 4-6 are objected to as being dependent upon a rejected base claim but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the prior art Birmingham discloses wherein the drilling comprises: mounting a drill guide 140 to the excision surface 151, the drill guide 140 comprising a first part 144 for abutting the excision surface and drill guide arms 148 and the tip having a pointed arm extending from opposite sides of the first part 144. However, Brimingham does not expressly disclose nor render obvious the arms having drill guide holes for guiding drilling; screwing a drill guide pin to a drill guide hole, thereby compressing the drill guide arms against the femur; and moving a drill bit through the drill guide pin prior to drilling into the femur. Claims 5 and 6 are dependent on claim 4.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: the specification, paragraph [00126] describes a guide arm 340 having threaded hole 345. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claims 12, 16 and 19-20 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 12 recites the limitation "the arms" in lines 1-4. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 includes the limitation “substantially parallel” in line 2. The use of “substantially parallel” is terminology of relative degree, which has no basis of comparison. For this reason, it is considered broad and relatively unlimited. The examiner asserts that the claimed physical property (in this case, substantially parallel) is present in the prior art material to some extent even though it is not explicitly recited. Therefore, the examiner hereby burdens the applicant to show that this property is not present.
Regarding Claims 19 and 20, the claim limitation “a fixing means extending between the arm holes and through the femur” as claimed in claim 19 and “the fixing means is a pin with at least one fixing hole extending through the pin at an angle to the longitudinal axis of the pin, the at least one fixing hole being provided towards a distal end of the pin” as claimed in claim 20 has been evaluated under the three-prong test set forth in MPEP § 2181, subsection I, but the result is inconclusive. Thus, it is unclear whether this limitation should be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because claim 19 does recite a function along with sufficient structure and claim 20 recites the structure but does not provide but does not provide any function. The boundaries of this claim limitation are ambiguous; therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
In response to this rejection, applicant must clarify whether this limitation should be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Mere assertion regarding applicant’s intent to invoke or not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph is insufficient. Applicant may:
(a) Amend the claim to clearly invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, by reciting “means” or a generic placeholder for means, or by reciting “step.” The “means,” generic placeholder, or “step” must be modified by functional language, and must not be modified by sufficient structure, material, or acts for performing the claimed function;
(b) Present a sufficient showing that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, should apply because the claim limitation recites a function to be performed and does not recite sufficient structure, material, or acts to perform that function;
(c) Amend the claim to clearly avoid invoking 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, by deleting the function or by reciting sufficient structure, material or acts to perform the recited function; or
(d) Present a sufficient showing that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, does not apply because the limitation does not recite a function or does recite a function along with sufficient structure, material or acts to perform that function.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 12 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 12 depends from claim 1, however claim 1 does not include any recitation to “arms,” the limitation directed to arms, arms having arm holes was only described in claim 7. Therefore, claim 12 should have depended from claim 7. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. For examination purposes, the examiner interpreted claim 12 to be dependent from claim 7.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Birmingham U.S. Publication 2014/0031948 A1.
Regarding Claim 1, Birmingham discloses a method for treatment of a hip joint (abstract and paragraphs [0006-0008]) comprising: fitting a buffer 180/172 to an excision surface 151 of a femur 122 from which a femoral head has been excised (abstract and paragraphs [0006-0013], [0035-0037] and as seen in Figures 4 and 6)); and arranging the femur 122 so that the buffer 180/172 is disposed between the femur and at least a part of a socket of the hip joint (as seen in Figures 4 and 12 and paragraph [0042]).
Regarding Claim 2, Birmingham discloses drilling a hole into the femur 122 from which the femoral head has been excised (paragraphs [0040-0042]); and fitting a bottom surface (portion 180) of the buffer 180/172 to the excision surface using the hole (the hole created in the femoral head receives a screw 184 to secure the bottom prosthesis 180 to the reamed surface of the femur).
Regarding Claim 3, Birmingham discloses wherein the hole 190 (as seen in Figures 11A-11E) is spaced apart from the excision surface (the hole extends through the femur beyond the surface 151 of the excision).
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.
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.
Claim(s) 7-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Birmingham U.S. Publication 2014/0031948 A1 in view of Wall U.S. Patent 4,502,161.
Regarding Claim 7, Birmingham discloses wherein the buffer 180/172 comprises: a main body adapted to be fitted to an excision surface 151; wherein the main body has a bottom surface 180 and an upper part 170 spaced in a first direction from the bottom surface, a size of the main body in at least one direction in plan view is larger than a corresponding size of an opening of the acetabular socket of the hip subject to treatment (as seen in Figure 12) and disposing the femur relative to the pelvis such that the buffer is disposed between the femur and at least a part of a pelvis around the hip socket whereby the upper part contacts the rim of the acetabular socket and sits outside the acetabular socket allowing for movement of the upper part relative to the acetabular socket (as seen in Figure 12). However, Birmingham does not expressly disclose arms having arm holes for attaching the arms to the sides of the femur, the arms are adapted to extend from the main body in a second direction away from the upper part and are positioned on opposite sides of the main body and the method comprising: attaching the arms to the femur such that the bottom surface abuts the excision surface. Wall et al. teaches a method of treating a hip joint in the same field of endeavor comprising a buffer 10 adapted to be fitted to an excision surface of a femur (column 4, lines 1-14), the buffer 10 comprises arms 12 having arm holes 15 (as seen in Figures 1 and 5 and column 3, lines 67-68) for the purpose of attaching the arms to the sides of the femur 16 (column 4, lines 1-14), the arms 12 are adapted to extend from the main body 11 in a second direction away from the upper part and are positioned on opposite sides of the main body (as seen in Figure 1 and 5), wherein the Wall et al. teaches the method of attaching the arms 12 to the femur such that the bottom surface abuts the excision surface (as seen in Figure 5, the bottom surface is the internal surface that articulates with the femur 16 and the upper part is what articulates with the tibia, see column 4, lines 1-14). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Birmingham’s buffer to further include arms having arm holes as taught by Wall et al. for the purpose of attaching the arms to the sides of the femur.
Regarding Claim 8, Birmingham discloses the upper part 180 of the buffer comprises a polymer (paragraph [0043]) and abut at least a part of the pelvis around the hip socket (as seen in Figure 12). However, Birmingham does not expressly disclose wherein the upper part comprises a resilient material. Wall et al. teaches a method of treating a hip joint in the same field of endeavor comprising a buffer 10 adapted to be fitted to an excision surface of a femur (column 4, lines 1-14), the buffer 10 is formed from resilient inert material such as Teflon or silicone rubber (column 3, lines 24-67) for the purpose of having a slick surface that is movable with respect to the articular surface of the bone to provide desired cushioning and lubrication functions (column 3, lines 25-48). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Birmingham’s buffer to be formed from a resilient polymer as taught by Wall et al. for the purpose of having a slick surface that is movable with respect to the articular surface of the bone to provide desired cushioning and lubrication functions.
Regarding Claim 9, Brimingham discloses wherein the upper part 180 includes a substantially flat surface (as seen in Figure 12).
Regarding Claim 10, Brimingham discloses wherein a curved side surface joins the bottom surface and the flat surface of the upper part 170 (see Figure 10).
Regarding Claim 11, Brimingham discloses wherein the bottom surface of the buffer 180/170 is substantially flat (the bottom surface forms a flattened region to receive the femur, see Figures 11A-11E).
Regarding Claim 12, Birmingham does not expressly disclose wherein the arms are connected to the buffer with a hinge, the method comprising moving the arms from a first position in which the apparatus is flat with the arms parallel to the main body and a second position in which the apparatus is folded with the arms extending in the second direction away from the upper part. Wall et al. teaches a method of treating a hip joint in the same field of endeavor comprising a buffer 10 adapted to be fitted to an excision surface of a femur (column 4, lines 1-14), the buffer 10 comprises arms 12 having arm holes 15 (as seen in Figures 1 and 5 and column 3, lines 67-68) and connected to the buffer 10 with a hinge (the curved/groove as seen in Figures 1 and 5), wherein Wall et al. teaches the buffer 10 is formed from resilient inert material such as Teflon or silicone rubber (column 3, lines 24-67) for the purpose of having a slick surface that is movable with respect to the articular surface of the bone to provide desired flexibility (column 3, lines 25-48), therefore, Wall’s arms formed of resilient material and movable can become flat or parallel to the main body and be folded (along the hinges of the arms, as seen in Figures 1 and 5) extending in a second direction away from the upper part (as seen in Figures 1 and 5) for the purpose of attaching the arms to the sides of the femur 16 and securing the device to the femur (column 4, lines 1-14). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Birmingham’s buffer to further include arms having a hinge to allow the arms to be resilient and movable to flex between a first position, flat state where the arms are parallel to the main body and a second position wherein the arms are folded as taught by Wall et al. for the purpose of for the purpose of attaching the arms to the sides of the femur and securing the device to the femur.
Regarding Claim 13, 14, Birmingham does not expressly disclose wherein the buffer and arms are formed with a unitary body of a resilient material and the hinge is a living hinge, wherein the living hinge is formed by a groove between the buffer and the arms, wherein the upper part and an outer surface of the arms form a continuous flat surface in the first position. Wall et al. teaches a method of treating a hip joint in the same field of endeavor comprising a buffer 10 adapted to be fitted to an excision surface of a femur (column 4, lines 1-14), the buffer 10 comprises arms 12, the arms 12 connected to the buffer 10 with a hinge (the curved/groove as seen in Figures 1 and 5), the buffer and arms are formed with a unitary body (as seen in Figures 1 and 5 and column 3, lines 67-68) formed from resilient inert material such as Teflon or silicone rubber (column 3, lines 24-67) for the purpose of having a slick surface that is movable with respect to the articular surface of the bone to provide desired flexibility (column 3, lines 25-48), therefore, Wall’s arms formed of resilient material and movable can become flat or parallel to the main body and be folded (along the hinges of the arms, as seen in Figures 1 and 5) extending in a second direction away from the upper part (as seen in Figures 1 and 5) for the purpose of attaching the arms to the sides of the femur 16 and securing the device to the femur (column 4, lines 1-14). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Birmingham’s buffer to further include arms that is a unitary body of resilient material and movable to flex between a first position, flat state where the arms are parallel to the main body and a second position wherein the arms are folded as taught by Wall et al. for the purpose of for the purpose of attaching the arms to the sides of the femur and securing the device to the femur.
Regarding Claim 15, Birmingham does not expressly disclose wherein the upper part and an outer surface of the arms form a continuous flat surface in the first position. Wall et al. teaches a method of treating a hip joint in the same field of endeavor comprising a buffer 10 adapted to be fitted to an excision surface of a femur (column 4, lines 1-14), the buffer 10 comprises arms 12, the arms 12 connected to the buffer 10 with a hinge (the curved/groove as seen in Figures 1 and 5), the buffer and arms are formed with a unitary body (as seen in Figures 1 and 5 and column 3, lines 67-68) formed from resilient inert material such as Teflon or silicone rubber (column 3, lines 24-67) for the purpose of having a slick surface that is movable with respect to the articular surface of the bone to provide desired flexibility (column 3, lines 25-48), therefore, Wall’s arms formed of resilient material and movable so it can become flat or parallel to the main body in the first direction (as seen in Figures 1 and 5). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Birmingham’s buffer to further include arms that is a unitary body of resilient material and movable to flex between a first position to allow the device to be movable with respect to the articular surfaces (column 3, lines 24-37).
Regarding Claim 16, Birmingham does not expressly disclose wherein an axis of the arm holes of the arms extending from the buffer in the second direction away from the upper part is substantially parallel to the bottom surface. Wall et al. teaches a method of treating a hip joint in the same field of endeavor comprising a buffer 10 adapted to be fitted to an excision surface of a femur (column 4, lines 1-14), the buffer 10 comprises arms 12 having arm holes 15 (as seen in Figures 1 and 5 and column 3, lines 67-68) extending in a second direction away from the upper part (the upper part articulates with the tibia 17, see Figure 5) and is substantially parallel to the bottom surface (the surface that articulates with the femur 16, see Figure 5) for the purpose of having arms that are flexible to be moveable with the articulating surfaces and allow attachment of the arms to the sides of the femur 16 (column 4, lines 1-14). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Birmingham’s buffer to further include arms having arm holes that extends in a second direction away from an upper part of the buffer and is substantially parallel to the bottom surface of the buffer as taught by Wall et al. for the purpose of having arms that are flexible to be moveable with the articulating surfaces and allow attachment of the arms to the sides of the femur.
Regarding Claim 17, Brimingham discloses wherein a width and length of the buffer in plan view are larger than corresponding dimensions of the opening of the acetabular socket (as seen in Figure 12).
Regarding Claim 18, Brimingham discloses wherein a perimeter of the buffer is larger than a perimeter of the acetabular socket (as seen in Figure 12).
Regarding Claim 19, 20, Birmingham does not expressly disclose fitting a fixing means extending between the arm holes and through the femur, wherein the fixing means is a pin with at least one fixing hole extending through the pin at an angle to the longitudinal axis of the pin, the at least one fixing hole being provided towards a distal end of the pin. Wall et al. teaches a method of treating a hip joint in the same field of endeavor comprising a buffer 10 adapted to be fitted to an excision surface of a femur (column 4, lines 1-14), the buffer 10 comprises arms 12 having arm holes 15 (as seen in Figures 1 and 5 and column 3, lines 67-68) and a fixing means, in the form of pins 28 extending between the arm holes 15 and the femur 16 for the purpose of attaching the arms to the sides of the femur and securing the device to the femur (column 4, lines 1-14). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Birmingham’s buffer to further include arms having arm holes as taught by Wall et al. for the purpose of attaching the arms to the sides of the femur.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEEMA MATHEW whose telephone number is (571) 270-1452. The examiner can normally be reached on Monday-Friday 9 am – 5 pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, SPE, Melanie Tyson at (571) 272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEEMA MATHEW/
Primary Examiner, Art Unit 3774
