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 Objections
Claim 1 is objected to because of the following informalities: In Line 10, the word “having” should be added deleted. Appropriate correction is required.
Claim 12 is objected to because of the following informalities: In Line 17, the word “having” should be added deleted. Appropriate correction is required.
Claim 19 is objected to because of the following informalities: In Line 11, the word “having” should be added deleted. Appropriate correction is required.
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 21 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 21 recites “wherein the plurality of tabs flex outward to receive the taper and create an interference fit with at least a portion of the taper.” which renders the claim indefinite as Claim 21 depends from Claim 1 which previously recites a taper of at first wall portion of the recess of the trial head, and thus it is unclear how the tabs of the trial head which comprises the recess can receive the taper of the recess. It appears the claim is intending to recite the “femoral prosthesis or trial femoral component” and not the taper. For purposes of examination, the claim is being interpreted as such. Appropriate correction is required.
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.
Claim(s) 1, 2, 5, 10-13, 16, 18 & 21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Belew et al. (US PG Pub No. 2012/0239160).
Regarding Claim 1, Belew et al. discloses a trial head (104, Figs. 2A-2B, 3A-3B, 1, 4 & 5, Paragraphs [0023-0026, 0031-0040]) for a hip arthroplasty comprising: a proximal side; a distal side; a plurality of tabs positioned at the distal side (projections 240, See examiner annotated Fig. 2A below), wherein the plurality of tabs collectively form an opening (aperture defined by free ends of the projections 240, Fig. 2A); and a recess (cavity 220, Fig. 2A, Paragraph [0031]) communicating with the opening, wherein the recess is configured to receive a trial femoral component (stem 102, Fig. 1, Figs. 3A-3B, Paragraph [0023, 0031]) wherein the recess is formed by at least a first wall portion having a taper, a second wall portion, a third wall portion, and a proximal end wall, wherein the first wall portion forms a distal-most part of the recess and is at least partially formed by the plurality of tabs, wherein the second wall portion has a geometry that differs from the first wall portion, and wherein the second wall portion is proximal to the first wall portion and is connected thereto, and wherein the third wall portion is proximal to the second wall portion and is connected thereto, wherein the third wall portion is distal of and spaced from the proximal end wall (See examiner annotated Fig. 3B below).
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Regarding Claim 2, Belew et al. discloses the second wall portion has a radius of curvature (See examiner annotated Fig. 3B above).
Regarding Claim 5, Belew et al. discloses further comprising an intermediate section between the proximal side and the distal side, wherein an exterior surface of the intermediate section has a groove therein (See examiner annotated Figs. 2A & 3B above).
Regarding Claim 10, Belew et al. discloses wherein at least the plurality of tabs are formed of a polymeric material (“Each of the head members 104-116 may be constructed of any suitable material useful for temporary surgical use. Such materials include, without limitation: polymeric materials, such as polyoxymethylene, polyetherimide, polyethylene, polypropylene, and polyphenyl sulfone.” Paragraph [0026]).
Regarding Claim 11, Belew et al. discloses wherein the distal side adjacent the plurality of tabs includes a lip (barbs 250, Fig. 2A) capable of facilitating removal of the trial head (Paragraphs [0032-0033]).
Regarding Claim 12, Belew et al. discloses an orthopedic system for a hip arthroplasty (100, Figs. 1, 4-6, 12, 19, Paragraph [0023]) comprising: a trial femoral component (stem 102, Fig. 1 & 3A-3B, Paragraph [0023, 0031]) that includes a neck having a taper (See examiner annotated Fig. 3B above and part of figure 1 below), wherein the trial femoral component represents a geometry of a femoral implant (Paragraphs [0024-0025]); a plurality of trial heads of different external configurations (104 & 106, Figs. 1, 4-6, 2A-2B & 3A-3B), wherein each of the plurality of trial heads is configured to couple with the trial femoral component (Paragraph [0025]), and wherein each of the plurality of trial heads includes: a proximal side (upper portion above groove, Figs. 1 & 4); a distal side (lower portion below groove, Figs. 1 & 4); a plurality of tabs positioned at the distal side (projections 240 of 104, See examiner annotated Fig. 2A above; and projections within 106, not labeled, Fig. 4), wherein the plurality of tabs collectively form an opening (aperture into recess defined by tabs, See examiner annotated Fig. 2A above; and Fig. 4), wherein an inner chamfered surface of each of the plurality of tabs (See examiner annotated Fig. 3B depicting 104, which is the same as the structure of 106, since 106 is not shown in detail in any figures) is configured to extend distal of a base of the taper when the trial femoral component is coupled with a respective one of the plurality of trial heads (Figs. 3A-3B); and a recess (See examiner annotated Fig. 3B above for 104, which is the same as the structure of 106) communicating with the opening and configured to receive the taper upon insertion of the taper past the inner chamfered surface of each of the plurality of tabs (Figs. 3A-3B, Paragraphs [0024-0026]), wherein the recess is formed by at least a first wall portion having a taper, a second wall portion, a third wall portion, and a proximal end wall, wherein the first wall portion forms a distal-most part of the recess and is at least partially formed by the plurality of tabs, wherein the second wall portion has a geometry that differs from the first wall portion, and wherein the second wall portion is proximal to the first wall portion and is connected thereto, and wherein the third wall portion is proximal to the second wall portion and is connected thereto, wherein the third wall portion is distal of and spaced from the proximal end wall (See examiner annotated Fig. 3B above depicting 104 which has the same recess structure as the structure of 106).
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Regarding Claim 13, Belew et al. discloses wherein at least the recess and the plurality of tabs have a same configuration for all of the plurality of trial heads (each of 104 & 106 have a structurally similar recess as seen in Fig. 4).
Regarding Claim 16, Belew et al. discloses wherein the plurality of tabs are configured to flex outward to receive the taper (“Each of the head members 104-116 may be constructed of any suitable material useful for temporary surgical use. Such materials include, without limitation: polymeric materials, such as polyoxymethylene, polyetherimide, polyethylene, polypropylene, and polyphenyl sulfone.” Paragraph [0026]. Polyethylene and polypropylene are well-known to be flexible materials.) and create an interference fit with at least a portion of the taper (Paragraphs [0024-0026]).
Regarding Claim 18, Belew et al. discloses wherein the distal side adjacent the plurality of tabs includes a lip (barbs 250, Fig. 2A).
Regarding Claim 21, Belew et al. discloses wherein the plurality of tabs are configured to flex to form an interference fit with the taper (Figs. 3A-3B, “Each of the head members 104-116 may be constructed of any suitable material useful for temporary surgical use. Such materials include, without limitation: polymeric materials, such as polyoxymethylene, polyetherimide, polyethylene, polypropylene, and polyphenyl sulfone.” Paragraph [0026]. Polyethylene and polypropylene are well-known to be flexible materials.).
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, 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) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Belew et al. (US PG Pub No. 2012/0239160).
Regarding Claim 4, Belew et al. discloses the claimed invention as stated above in claim 1, except wherein the third wall portion is cylindrically shaped. It appears from Fig. 3B that the third wall is cylindrically shaped, but the shape not specifically disclosed. Paragraph [0031] states that the cavity 220 is defined by walls that are configured to mate with an exterior surface of a component of the stem and Figs. 3A-3B depict the uppermost portion of the stem engaging with the third wall portion when fully assembled. It would have been an obvious matter of design choice to a person of ordinary skill in the art before the effective filing date of the invention to modify the third wall portion to be cylindrical because the Applicant has not stated that having a cylindrical third wall portion provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art would have expected Belew’s implant and the Applicant's invention to perform equally well with the third wall portion taught by Belew or the claimed "cylindrical third wall portion” because both would perform the same function of correspondingly accepting an uppermost portion of the neck of the stem when the stem had a cylindrically shaped neck. Therefore, such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Belew et al.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Belew et al. (US PG Pub No. 2012/0239160) in view of Bushell et al. (WIPO Pub No. WO 2018/189128).
Regarding Claim 17, Belew et al. discloses the claimed invention as stated above in claim 12, and further discloses a wall defining a part of the recess having a radius of curvature (2nd wall portion, See examiner annotated Fig. 3B above). Belew et al. does not disclose wherein the trial femoral component incudes a C-ring at the taper, and wherein the wall that defines the part of the recess with the radius of curvature is configured to create an interference fit with the C-ring when the taper is received by the plurality of tabs and the recess.
Bushell et al. discloses a femoral trialling kit and assembly (Figs. 12-16), comprising a trial hip joint (500, Fig. 12, Pg. 14, Line 24 – Pg. 19, Line 26) comprising a trial femoral component in the form of a reamer or broach stem component (510), a trial femoral neck (512/612, Figs. 12-16) releasably attached to an upper portion of the stem component, and a trial femoral head (514/614, Figs. 12-14) releasably attached to the trial femoral neck, wherein a rubber, silicone, or metal C-ring (564/664, Fig. 14) is retained in a groove (662) of a taper (660) of the trial femoral neck (612) and interacts between the taper and a corresponding groove within and extending around an interior wall of the trial head to provide a retention mechanism by which the head may be releasably attached to the trial neck (Pg. 18).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the taper of the trial femoral component of Belew et al. to include a C-ring for being retained within the groove at the 2nd wall portion as taught by Bushell et al. in order to provide an added retention means between each trial head and the removably attached femoral component.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Belew et al. (US PG Pub No. 2012/0239160) in view of Mears et al. (US PG Pub No. 2003/0220698).
Regarding Claim 19, Belew et al. discloses a method of trialing for a hip arthroplasty comprising: providing a femoral prosthesis with a neck having a taper (102, See examiner annotated Fig. 1 above, Paragraphs [0023-0024]); preparing a femur to receive the femoral prosthesis (“cavity formed in a femur of a subject”, Paragraph [0024]); inserting the femoral prosthesis in the femur (“The stem 102 includes an elongated shaft configured to be inserted in a cavity formed in a femur of a subject.”, Paragraph [0024]); coupling a first (“selected head member”, Paragraph [0027]) of a plurality of trial heads (104 & 106, Figs. 1, 4-6, 2A-2B & 3A-3B) with different external configurations to the femoral prosthesis (“Each of the head members 104-116 is configured to engage, or mate with, the stem 102”, Paragraph [0025]) by receiving the taper within a recess (See examiner annotated Fig. 3B above for 104, which is the same as the structure of 106) and capturing the taper with a plurality of tabs of the first of the plurality of trial heads (Figs. 3A-3B) (See examiner annotated Fig. 3B & 2A above), wherein the plurality of tabs are configured to flex to form an interference fit with the taper (Figs. 3A-3B, “Each of the head members 104-116 may be constructed of any suitable material useful for temporary surgical use. Such materials include, without limitation: polymeric materials, such as polyoxymethylene, polyetherimide, polyethylene, polypropylene, and polyphenyl sulfone.” Paragraph [0026]. Polyethylene and polypropylene are well-known to be flexible materials.), and wherein the recess is formed by at least a first wall portion having a taper, a second wall portion, a third wall portion, and a proximal end wall, wherein the first wall portion forms a distal-most part of the recess and is at least partially formed by the plurality of tabs, wherein the second wall portion has a geometry that differs from the first wall portion, and wherein the second wall portion is proximal to the first wall portion and is connected thereto, and wherein the third wall portion is proximal to the second wall portion and is connected thereto, wherein the third wall portion is distal of and spaced from the proximal end wall (See examiner annotated Fig. 3B above depicting 104 which has the same recess structure as the structure of 106).
Belew et al. does not disclose the step of performing a trial reduction with the first of the plurality of trial heads coupled to the trial femoral component or femoral prosthesis. One having ordinary skill in the art would recognize that it is well known and common to perform a trial reduction prior to insertion of the final prosthesis parts and completion of the surgery.
Mears et al. discloses a method and apparatus for performing a minimally invasive total hip arthroplasty (Paragraphs [0088-0106]), comprising preparing the femur and femoral canal (Paragraphs [0101-0104]) for a femoral prosthesis, seating a femoral component in the femoral canal (Paragraphs [0104-0105]), selecting a trial liner and a trial head and placing the selected trial head on a neck of the femoral component (Paragraph [0105]), reducing the hip joint for an assessment of stability of the hip joint and limb length, and where necessary, making a second assessment, and once the trial reduction is satisfactorily completed, the hip is dislocated and the provisional head and provisional neck 222 are removed (Paragraph [0105]), and wherein “In an alternative embodiment, a trial reduction can be performed utilizing the final femoral implant and a trial femoral head.”
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of Belew et al. to add the step of performing a trial reduction with the first of the plurality of trial heads coupled to the femoral prosthesis as taught by Mears et al. in order to allow an assessment of the stability of the hip joint and limb length to be made prior to placement of the final prosthesis components which reduces dislocation risk and contributes to a more successful post-surgical outcome.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Belew et al. (US PG Pub No. 2012/0239160) in view of Mears et al. (US PG Pub No. 2003/0220698) as applied to Claim 19 above and further in view of Bushell et al. (WIPO Pub No. WO 2018/189128).
Regarding Claim 20, the combination of Belew et al. and Mears et al. discloses the claimed invention as stated above in claim 19, and Belew et al. further discloses wherein coupling the first of the plurality of trial heads to the femoral prosthesis includes positioning an inner chamfered surface of each of the plurality of tabs (See examiner annotated Fig. 3B above) to extend distal of a base of the taper (Figs. 3A-3B), wherein a wall of each recess has a radius of curvature (2nd wall portion, See examiner annotated Fig. 3B above), and wherein each trial head comprises a lip (See examiner annotated Fig. 3B above) located adjacent the plurality of tabs.
The combination does not disclose forming an interference fit within the recess between a C-ring coupled to the taper and the wall of the recess; and removing the first of the plurality of trial heads from the femoral prosthesis by grasping the lip located adjacent the plurality of tabs.
Bushell et al. discloses a femoral trialling kit and assembly (Figs. 12-16), comprising a trial hip joint (500, Fig. 12, Pg. 14, Line 24 – Pg. 19, Line 26) comprising a trial femoral component in the form of a reamer or broach stem component (510), a trial femoral neck (512/612, Figs. 12-16) releasably attached to an upper portion of the stem component, and a trial femoral head (514/614, Figs. 12-14) releasably attached to the trial femoral neck, wherein a rubber, silicone, or metal C-ring (564/664, Fig. 14) is retained in a groove (662) of a taper (660) of the trial femoral neck (612) and interacts between the taper and a corresponding groove within and extending around an interior wall of the trial head to provide a retention mechanism by which the head may be releasably attached to the trial neck (Pg. 18), and wherein the trial head comprises first and second depressions (676 & 678) for gripping when manipulating the trial head to facilitate removal of the trial femoral head from the trial femoral neck during use (Pg. 19, Lines 5-9).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the taper of the trial femoral component of the combination to include a C-ring for being retained within the groove at the 2nd wall portion as taught by Bushell et al. in order to provide an added retention means between each trial head and the removably attached femoral component.
Response to Arguments
Applicant’s amendments, filed 12/05/25, have overcome the drawing objections.
Applicant’s amendments, filed 12/05/25, have overcome the objections to claims 2, 9 & 17.
Applicant’s amendments, filed 12/05/25, have overcome the 112(b) rejections for claim 7.
In regards to Applicant’s arguments, filed 12/05/25, with respect to the Belew rejection of claims 1-8, 10-16 & 18: The Applicant’s arguments have been fully considered but are moot in view of the new grounds of rejection, based on the newly amended claims which changed the scope of the claims, using a new interpretation of Belew et al.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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 JESSICA WEISS whose telephone number is (571) 270-5597. The examiner can normally be reached Monday through Friday, 8:00 am to 4:00 pm EST. If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, KEVIN T. TRUONG, at 571-272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JESSICA WEISS/Primary Examiner, Art Unit 3775