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(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
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.
Claim 7 is rejected under 35 U.S.C. 112(a) and 112(b) as failing to comply with the written description requirement and as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. The claim contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, at the time the application was filed, had possession of the claimed invention. A coupler having male and female members (amended claim 1 at lines 7-13) in combination with the coupler being “monolithically formed with one or both of the load bearing component and the stem” (amended claim 7) is neither shown in the drawings nor described in the original specification, claims, and abstract. Additionally, the coupler being monolithically formed with both the load bearing component and the stem appears to be at odds with the angle adjustability feature as set forth in claim 1 at lines 14-16 and thus renders claim 7 vague, indefinite, and confusing as to the scope.
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 1-3, 7-9, and 14 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Thomas et al., US 2011/0054626 A1. Figures 1-3, for example, depict a knee prosthesis 10 comprising load bearing component 12 including a first connection mechanism 22 having a female member 32, a stem 16 for insertion into an intramedullary canal of a patient’s bone (paragraphs 0003-0004, 0028) and including a second connection mechanism having a male member 43, and a coupler 14 including a first end portion having a male member 28 defining a first central longitudinal axis 46 and a second end portion 40 having a female member 44 defining a second central longitudinal axis 48, male member 28 engaging female member 32 and female member 44 engaging male member 43 (paragraphs 0030, 0032). Axes 46 and 48 are non-intersecting (Figures 1 and 2), non-parallel (Figure 2), and offset from each other by a distance 50 (Figure 1); rotation of coupler 14 thus innately adjusts the varus/valgus angle of stem 16 relative to load bearing component 12 and facilitates reception of stem 16 in a bowed intramedullary canal (Figures 1-2; paragraphs 0005, 0033-0035). In the embodiments of Figures 1-8, coupler 14 is monolithically formed so that axes 46 and 48 are in a predetermined, non-adjustable configuration [paragraphs 0027, 0043, 0048 (contrasted with multiple piece coupler embodiments)].
Regarding claim 7, in another variant, the coupler is monolithically formed with the stem (Figures 7-8; paragraphs 0043+); the coupler lacks a female member (as set forth in Applicant’s claim 1), but neither does Applicant’s own original disclosure teach such a combination of elements, as explained above. Regarding claims 8-9 and 14, offset 50 (Figure 1) is capable (MPEP § 2114) of being oriented so as to lie along a medial/lateral plane, an anterior/posterior plane, or a plane angled from these planes but likewise extending along a superior/inferior dimension (paragraphs 0010, 0033, 0036) so as to define non-parallel axes components in both the coronal and the sagittal planes (similar to what is shown in Figure 2).
Claims 1-3 and 8-14 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Lu, US 8,721,729 B1. Figure 9 illustrates portions of a knee prosthesis (column 3, lines 38-43) comprising a load bearing component 2 including a first connection mechanism or extension portion having a receiving bore 21 (column 3, lines 36-38), a stem component 1 for insertion into an intramedullary canal of bone B (column 3, lines 34-35), and a coupler 31c having a first end portion 311c for engaging said bore 21 and defining a first central longitudinal axis C1 that can be non-intersecting, non-parallel, and offset by a distance relative to second central longitudinal axis C2 of stem component 32 [column 2, lines 35-37; column 3, lines 44-60; column 4, line 33, to column 5, line 2 (“the column body 311c is provided as being skew in relation to the base body 312, so that the longitudinal central axis of the first connecting component and the longitudinal central axis of the second connecting component are skew to each other”)], with “skew” being defined as “[neither] parallel nor intersecting” (Webster’s II New Riverside University Dictionary: 1984) and “skew lines” meaning “straight lines that do not intersect and are not in the same plane” (Merriam-Webster’s Collegiate Dictionary, 10th ed.: 1996). The first connecting portion 31c by itself is thus a coupler integrally and monolithically formed to have a predetermined, non-adjustable first central longitudinal axis C1 along column body 311c and second central longitudinal axis C2 through base body 312, with second connecting component 32 being part of the stem as claimed. Bump 323 is then viewed as the male member of the stem for engaging groove or female member 313 of monolithic coupler 31c (Figure 2). That an intramedullary stem may, by definition, be of multiple parts is evident from a cursory review of the prior art and from Applicant’s own specification, which states that a coupler “can also be referred to as an intermediate stem extension” (paragraph 0056, first sentence; emphasis added).
Regarding claim 1-3, 8-9, and 14, rotational adjustments to accommodate varus-valgus and flexion-extension angles are innate in the rotationally symmetric frusto-conical or Morse geometries depicted in Figures 2 and 9 and are further evident from the discussion in column 4, line 41, to column 5, line 9 [for example, “the stem means 1 may be selectively located in any orientations relative to the receiving means 2” (column 4, lines 51-53)]. Regarding claims 10-11, kits with a plurality of couplers having dissimilar offsets and/or angles are described in column 5, lines 2-9. Regarding claims 12-13, the structure and features of a chosen coupler from a kit are unaffected by the particular method of selection; in a product claim, “determination of patentability is based on the product itself” (MPEP § 2113).
Response to Arguments
Language added to amended claim 1 is broader in some respects than further limitations of canceled claim 6, for instance, and Lu is still applicable to the claims under “the alternate interpretation” (Applicant’s reply of March 5, 2026: page 6, last paragraph), as explained above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to David H. Willse, whose telephone number is 571-272-4762. The examiner can normally be reached on Monday through Thursday. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor Thomas Barrett can be reached at telephone number 571-272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID H WILLSE/ Primary Examiner, Art Unit 3774