Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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) 3, 14 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In regard to claim 3, the claim recites “an imaginary equator line”. Something imaginary cannot be claimed because it does not exist. The instant disclosure does not refer to an imaginary line but describes an equator line as a largest circumference. It is suggested to use this description which describes an actual physical aspect of the invention.
In regard to claim 14, “the distal, dorsal and proximal quadrant” lacks proper antecedent basis. “The” should be replaced with “a” to correct the issue.
Since claims 4-15 and 40-41 depend from claim 3, all claims are rejected under 112b.
Claim Objections
Claim 15 is objected to because of the following informalities:
In regard to claim 15, “at least ¼ of said equator line” includes anything above ¼ and accordingly the language “at least incorporates longer than ¼ which includes ½ and 1/3” should be removed since it is duplicative.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 3-15 and 40-41 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Richards (US 2005/0004678 A1) in view of Termanini (2014/0156011A1) and in view of Scales (3584318).
Regarding Claim 3, Richards discloses a medical device 12 for implantation in a hip joint (abstract), where the medical device 12 is adapted to be fixated to the femoral bone and receive a prosthetic replacement for the caput femur having a spherical portion (fixed to 150 as shown in figure 7 where 150 is a femoral head and therefore capable of being fixed to a femoral bone),
and to be fixated to the bone by a connection via an elongated member [0038: neck of femoral stem] fixated to said spherical portion 150 of said prosthetic caput femur (device 10 of Richards is adapted as such),
where an inner surface comprises an imaginary equator line (interpreted as best understood to refer to an imaginary line around the greatest part of the circumference of the device), defining a largest circular circumference of said inner surface of said medical device (Richards further discloses the inner contacting surface of element 16 comprising an equator line (see annotated figure 2; fig 1) being the largest circumference of the inner contacting surface),
at least two extending portions (tab 54) passing beyond said imaginary equator line, such that the end portion of the contacting portion of the inner surface forms a circular extension line (interpreted as another imaginary line about the circumference; since tables 54 are tilted inwards as shown in figure 7, this limitation has been met) having a smaller circumference than the equator line (see annotated figures),
and the at least one extending portion 54 of the two extending portions is adapted to circumferentially extend discontinuously along the equator line (see fig 3, 5, tabs do not create an entire circumference and therefore extend discontinuously),
such that a portion of the elongated member (femoral neck which fits within 152) can be placed between the extension line and said equator line, when the medical device being implanted together with the prosthetic replacement for the caput femur. (as seen in Figures 7 and 8 recess 152 is adapted to receive a neck of the femoral hip stem as described in [0038])
However, Richards does not teach that the medical device is adapted to be fixated to the pelvic bone by an elongate member or that a first distance between two extending portions is greater than a second distance between the at least two extending portions.
Termanini teaches the use of a reverse hip prosthesis and connecting the medical device to the pelvic bone using an elongate member 9.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to reverse the ball and acetabular cup of Richards using the elongate members of Termanini because this configuration prevents dislocation during extreme ranges of motion (abstract), improves weight distribution, decreases wear on contact surfaces and reduces the risk of wear particles being released in the joint [0015].
Scales teaches a first distance along the imaginary equatorial circumference between the at least two extending portions is greater than a second distance along the imaginary equatorial circumference between the at least two extending portions on an opposite side thereof (see multiple extending portions 4, 6 in figure 3; the distance between any two extending portions is unequal on opposite sides).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use more extending portions as taught by Scales, in the configuration taught by Scales because this helps ensure the bearing surface is correctly positioned (Col 2, lines 63-68).
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Regarding Claims 4 and 5, Richards discloses the medical device according to claim 3, and further discloses that the imaginary extension line is placed dorsal to the equator line (see annotated figures), when the medical device 12 is implanted and at least one extending portion 54 of the at least two extending portions is adapted to extend circumferentially along said equator line (fig 2, 7),
dorsal to the right-left axis of pelvis when being in a defined base position (as no orientation parameters are given for these functional limitations, the extending portions of Richards are capable of meeting this limitation when implanted).
Regarding Claims 4-9, Richards discloses the device of claim 3, and discloses a device capable of being placed such that the extension line is placed dorsal to the equator line (see annotated figure), when the medical device 12 is implanted, at least one extending portion 54 is adapted to extend circumferentially along the equator line (fig 2, 7), dorsal to the right-left axis of pelvis when being in a defined base position, and the at least one extending portion 54 extending circumferentially along the equator line (see annotated figures), dorsal to the coronal pelvis plane PXY and proximal to the horizontal pelvis PXZ plane when being in a defined base position,
and the at least one extending portion 54 of the at least two extending portions is adapted to extend circumferentially along said equator line (see annotated figures), dorsal to the coronal pelvis plane PXY and distal to the horizontal pelvis PXZ plane when being in a defined base position (as seen in Figures 7 and 8, the device of Richards is capable of meeting these limitations as claimed).
Regarding Claim 9, Richards discloses the device according to claim 3, and further discloses that at least one extending portion 54 of the at least two extending portions is adapted to extend circumferentially along said equator line (see annotated figures), in the proximal quadrant of the equator line when being in a defined base position (as no orientation parameters are given for this functional limitation, the extending portions of Richards meet this limitation). A base position could be any position. Accordingly, the extending portion 54 will extend along the equator line in the proximal quadrant in some orientation.
Regarding Claim 10, Richards discloses the device according to claim 3, and further discloses that at least one extending portion 54 of the at least two extending portions extends circumferentially along said equator line (they extend around the outer circumference as shown in figure 3), in the distal quadrant of the equator line when being in a defined base position (as no orientation parameters are given for this functional limitation, the extending portions of Richards in view of Scales meet this limitation).
Regarding Claim 11, Richards discloses the device according to claim 3, and further discloses that said two extending portions 54 (see Figure 1) are adapted to extend circumferentially along said equator line (see annotated figures), in the distal and proximal quadrant thereof when being in a defined base position (as no orientation parameters are given for this functional limitation, the extending portions of Richards in view of Scales meet this limitation).
Regarding Claim 12, Richards discloses the device according to claim 3, at least one extending portion 54 of the at least two extending portions is adapted to extend circumferentially along said equator line (see annotated figures), in the proximal and dorsal quadrant thereof when being in a defined base position (as no orientation parameters are given for this functional limitation, the extending portions of Richards meet this limitation).
Regarding Claim 13, Richards discloses the device according to claim 3, and further discloses that at least one extending portion 54 of said at least two extending portions is adapted to extend circumferentially along said equator line (see annotated figures), in the distal and dorsal quadrant thereof when being in a defined base position (as no orientation parameters are given for this functional limitation, the extending portions of Richards in view of Scales meet this limitation).
Regarding Claim 14, Richards discloses the device according to claim 3, and further discloses that at least one extending portion 54 of said at least two extending portions is adapted to extend circumferentially along said equator line, in the distal, dorsal and proximal quadrant thereof when being in a defined base position (as no orientation parameters are given for this functional limitation, the extending portions of Richards in view of Scales meet this limitation).
Regarding Claim 15, Richards discloses the device according to claim 3, and further discloses
that at least a first portion of the medical device 12 is one of the extending portions 54, extending beyond the circular equator line (see annotated figures),
and at least a second portion (at 46) is a portion not extending beyond said circular equator line (see annotated figures), wherein the second portion (at 46) circumferentially extends along at least of the circular equator line (see annotated figures), at least incorporates longer than ½ which includes ½ and 1/3 said circular equator line. As shown in figure 2, the medical device at 46 and proximal to 46, extends around the entire circumference and is therefore along the entire equator line, meeting the limitations of at least 1/4 of the equator line. The portions between 46 do not extend beyond the equator line distally. The direction of beyond is not defined in the claim.
Regarding Claim 40, Richards discloses a method using a medical device 12 of claim 3, for implantation in a hip joint of a patient (abstract), comprising the steps of fixating said medical device 12 to the femoral bone of the patient ([0038]), and where the medical device 12 comprises an inner and an outer surface (Figure 1, inner surface 16, outer surface 14), where a contacting portion of the inner surface is bowl shaped and spherical and adapted to face the center of the hip joint (inner surface of 16),
placing the inner bowl shaped surface 16 facing proximally towards the center of the hip joint, and fixating a prosthetic replacement for the caput femur fixated to the pelvic bone having a ball shaped spherical portion 150 receiving said prosthetic replacement for the caput femur inside said inner bowl shaped surface 16 (as seen in Figures 7 and 8 and described in [0038]), where the medical device 12 comprises at least one extending portion (54), extending said contacting portion of said inner surface 16 such that said at least one extending portion 54 clasps said spherical portion 150, clasping said prosthetic replacement for the caput femur 150, such that said spherical portion is restrained in said bowl shaped inner surface 16 of said medical device ([0038]). (fig 7)
However, as discussed in the rejection of claim 3, Richards does not teach that the first distance between the extending portions is greater than a second distance between the two extending portions.
Scales teaches a first distance along the imaginary equatorial circumference between the at least two extending portions is greater than a second distance along the imaginary equatorial circumference between the at least two extending portions on an opposite side thereof (see multiple extending portions 4, 6 in figure 3). This claim language is interpreted as best understood to refer to the placement of the extending portions.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use more extending portions as taught by Scales, in the configuration taught by Scales because this helps ensure the bearing surface is correctly positioned (Col 2, lines 63-68).
Regarding Claim 41, Richards discloses the method according to claim 40, where the medical device 12 is adapted to receive the spherical portion of the prosthetic replacement for the caput femur 150 (fig 7),
an elongated member [0038: neck, within 152] fixated to said spherical portion 150 of said prosthetic caput femur (Figures 7 and 8), where the inner surface comprises an equator line (see annotated figure), being the largest circular circumference of said inner surface 16 (see annotated figure)
at least one extending portion (tab 54) passing beyond said equator line (see annotated figures), such that the end portion of the contacting portion of the inner surface 16 forms a circular extension line having a smaller circumference than the equator line (see annotated figures),
and the at least one extending portion 54 circumferentially extends discontinuously along the equator line (see annotated figures, tabs 54 are discontinuous), such that a portion of the elongated member [0038: neck] can be placed between the extension line and said equator line (see annotated figures), when the medical device 12 being implanted together with the prosthetic replacement for the caput femur 150.
However, Richards does not teach that the elongated member is connected to the pelvic bone.
Termanini teaches the use of a reverse hip prosthesis and connecting the medical device to the pelvic bone using an elongate member 9.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to reverse the ball and acetabular cup of Richards using the elongate members of Termanini because this configuration prevents dislocation during extreme ranges of motion (abstract), improves weight distribution, decreases wear on contact surfaces and reduces the risk of wear particles being released in the joint [0015].
Response to Arguments
In regard to the drawing objections, the objection has been reconsidered and withdrawn with reference to the elected embodiment.
In regard to the 112b rejection of claims 3-15 and 40, the applicant’s amendments have been fully considered. Regarding claim 3, while the original 112b issue is overcome, the amendments have created a new 112b issue as noted above.
In regard to the claim objections,
In regard to the 101 rejection of claims 5-8, the amendments have overcome the rejections.
Regarding claims 9-14, the amendments correct the antecedent issues in claims 9-13. The antecedent issue in claim 14 has not been addressed. The amendments claim 15 overcome the 112b rejection. The amendment to claim 40 overcomes the 112b rejection.
In regard to the 101 rejection of claims 5-8, the amendments overcome the rejection.
In regard to the 103(a) rejection of claims 3-15 and 40-41 as unpatentable over Richards (2005/0004678A1) in view of Termanini (2014/0156011A1), the applicant’s arguments have been fully considered but are all directed toward new claim limitations which have been addressed above.
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 CHRISTIE BAHENA whose telephone number is (571)270-3206. The examiner can normally be reached M-F 9-3.
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/CHRISTIE BAHENA/Primary Examiner, Art Unit 3774