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 .
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 15 is 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 15 recites the limitation "from an outer edge to a center of posterior side" in line 2. It is unclear what the outer edge and center of posterior side are; The outer edge and posterior side of what? For examination, the limitation is interpreted to mean --from an outer edge of the patella implant to a center of the posterior side of the patella implant--.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Afriat FR 2 976 176 A1 (hereafter referred to as Afriat; refer to the attached translation for passages referenced herein).
Regarding claim 1, Afriat discloses a knee implant comprising a femoral component 2 arranged and configured to engage a patient's femur (the femoral component 2 is capable of engaging a patient’s femur), the femoral component including an articular surface (outer surface opposite the bone engaging surface in figs. 1 and 4) arranged and configured to articulate relative to a tibial component 4 or insert 5 (figs. 1-3; tibial component/insert are not positively claimed because of “configured to”), wherein the articular surface includes a patella path 12 along which a patella travels, the patella path 12 including a constraint region (distal region of path 12 shown in fig.4) and a reduced constraint region (proximal region of path 12 shown in fig.4), the reduced constraint region being arranged and configured to provide increased freedom-of-movement of the patella as it travels over the reduced constraint region compared to freedom-of-movement of the patella as it travels over the constraint region (figs. 7-7D show the increased freedom of movement of the patella in the reduced constraint region while figs. 8-11 show less freedom of movement; pg.2, pars. 1-3 discloses the different freedom of movement for each region). The examiner notes that no patella or patella implant is positively claimed in claims 1-12 and the claims are directed to the femoral component only in light of the use of “configured to” which is functional.
Regarding claim 2, see figs. 7A and 7B for increased medial-lateral movement compared to no medial-lateral movement in figs. 8-11.
Regarding claims 3-4, figs. 7-11 show the different medial-lateral freedom of movement in the constraint region and the reduced constraint region. As discussed above, the claims do not positively recite a patella or patella implant. As such, the patella path of the femoral component of Afriat is capable of achieving the claimed percentages and differences since these values depend on both the claimed femoral component and a patella/patella implant which is not positively claimed. In other words, because the femoral component of Afriat has constraint and reduced constraint regions, wherein the reduced constraint region enables increased medial-lateral movement of the patella, a person could select or shape a patella/patellar implant to achieve increased medial-lateral movement of the patella/patella implant of about 105 percent to about 150 percent and about 1 mm to about 20 mm. It is also noted that Afriat fig.4 shows a gradual reduction in medial-lateral width of the patella path. Therefore, along this region of decreasing width a comparison of the medial-lateral movement at two locations can achieve the claimed percent/distance change.
Regarding claim 5, see figs. 7C and 7D for increased internal-external rotation of the patella compared to no internal-external rotation of the patella in figs. 8-11. This is discussed in pg.2, pars. 1-3 of the translation.
Regarding claim 6, figs. 7-11 show the different internal-external rotation in the constraint region and the reduced constraint region. As discussed above, the claims do not positively recite a patella or patella implant. As such, the patella path of the femoral component of Afriat is capable of achieving the claimed percentages since the percentage depends on both the femoral component and a patella/patella implant which is not positively claimed. In other words, because the femoral component of Afriat has constraint and reduced constraint regions, wherein the reduced constraint region enables increased internal-external rotation of the patella, a person could select or shape a patella/patellar implant to achieve increased internal-external rotation of the patella/patella implant of about 105 percent to about 150 percent. It is also noted that Afriat fig.4 shows a gradual reduction in medial-lateral width of the patella path. Therefore, along this region of decreasing width a comparison of the internal-external rotation at two locations can achieve the claimed percent change.
Regarding claim 7, see fig.4 of Afriat for a trochlear groove, located between condyles 11a, positioned inferiorly to the reduced constraint region.
Regarding claim 8, see figs. 7-11 for the patella being within the reduced constraint region during extension (fig.7) and within the trochlear groove during flexion (figs. 8-11).
Regarding claim 9, see figs. 7-7d for the patella residing within the reduced constraint region during extension which is less than about 10 degrees of flexion. Afriat further discloses the width and depth of the path 12 gradually decreases until it corresponds to the patella at 50 degrees of flexion (pg.3, lines 30-32). Therefore, the patella will reside within the reduced constraint region at least when the patella travels less than about 10 degrees of flexion.
Regarding claim 10, fig.7 shows a relatively flatter/flattened region in the proximal anterior flange of the femoral component, at least as compared to the region of the anterior flange as shown in figs. 8-11.
Regarding claim 11, a length of a distal anterior flange region is arbitrary, meaning a length can be defined for some arbitrary distal portion of the flange. A length of a reduced constraint region is also arbitrary. Because the path gradually gets wider any proximal part of the path can be considered reduced in constraint relative to a distal part of the path. As such, two arbitrary lengths can be selected to define the claimed percentage.
Regarding claim 12, because the path 12 gradually gets wider toward the proximal end, any proximal part of the path can be considered reduced in constraint relative to a distal part of the path. Therefore, one can arbitrarily define a reduced constraint region having a length of 1 mm to about 20 mm.
Regarding claims 13-15, see Afriat figs. 1-11 for a patella implant 3 capable of traveling along the patella path 12 of the femoral component. Fig.6 shows the patella implant includes a raised portion 22 on at least a distal region of a posterior side of the patella implant, wherein the raised portion 22 facilitates engagement of the patella implant with the constraint region of the patella path (figs. 8-11), and wherein the raised portion flairs out moving from an outer edge of the patella implant toward a center of a posterior side of the patella implant (fig.6).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Zhang et al. CN 111529138 discloses a knee implant comprising a femoral component having a patella path that has a constraint region and a reduced constraint region (figs. 1-6). Wellings et al. US 2018/0325685 discloses a knee implant comprising a femoral component having a patella path that has a constraint region and a reduced constraint region (fig.9). Wright et al. US 2014/0142714 discloses a knee implant comprising a femoral component having a patella path that has a constraint region and a reduced constraint region (figs. 3-11).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEGAN Y WOLF whose telephone number is (571)270-3071. The examiner can normally be reached Mon-Fri 6am-3pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached 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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/MEGAN Y WOLF/Primary Examiner, Art Unit 3774
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