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 .
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.
Specification
The incorporation of essential material in the specification by reference to an unpublished U.S. application, foreign application or patent, or to a publication is improper. Applicant is required to amend the disclosure to include the material incorporated by reference, if the material is relied upon to overcome any objection, rejection, or other requirement imposed by the Office. The amendment must be accompanied by a statement executed by the applicant, or a practitioner representing the applicant, stating that the material being inserted is the material previously incorporated by reference and that the amendment contains no new matter. 37 CFR 1.57(g).
The attempt to incorporate subject matter into this application by reference to an incorporation by reference statement added after an application’s filing date is ineffective because no new matter can be added to an application after its filing.
The amendment filed 08/09/2023 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows:
The incorporation by reference of the international patent application PCT/US2021/037144 and US application US17/145332 is ineffective as it was added after the date of entry into the national phase, which is after the filing date of the instant application. The filing date of this national stage application is the filing date of associated PCT, in this case 06/14/2021, see MPEP 1893.03(b). Therefore, the specification amendment of 08/09/2023 to include the incorporation by reference is new matter, per MPEP 608.01(p). Applicant is advised to remove the phrase “and incorporates by reference their full disclosures as if set forth herein” from the specification.
Applicant is required to cancel the new matter in the reply to this Office Action.
Claim Objections
Claim(s) 17 and 21 are objected to because of the following informalities:
In claim 17, line 3, “does not to exceed” should read “does not exceed”
In claim 21, line 2, “handheld compactor” should read “handheld impactor”
Appropriate correction is required.
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.
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) 14-21 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Loffredo (US 2017/0035571) and further in view of Katrana et al. (US 8246687).
Regarding claim(s) 14 and 21, Loffredo discloses a reverse hip prosthesis system comprising: a unitary acetabular cup (10) having a convex non-articulating surface (21) for attachment to an acetabular socket in a pelvic bone and a concave surface located opposite to the convex non-articulating surface, the concave surface having a central opening (23) said central opening providing a female Morse taper (9) adapted to receive a peg (20) having a corresponding male Morse taper (20) (see [0050], [0051] and [0052] disclosing an acetabular base (10) functioning as the unitary cup, an interface with the acetabulum (21) acting as the convex non-articulating surface, the inner portion of the base (10) designed to accept the acetabular ball (12) which forms a concave surface to receive the reverse hip geometry, a central opening (23) in the apex of the cup, and a cylindrical cavity (9) that engages the central barrel (20) which acts as the male and female morse tapers); an inner circular wall (20) having a narrow end and a larger end, wherein the larger end extends inside the concave space of the unitary acetabular cup (10) (see [0052] disclosing an a central barrel (20) which forms the structural equivalent of an inner circular wall, the opening (23) at the apex serving as the entry point for the central barrel (20) creating the large opening, a narrow end of the central barrel (20) which includes a keyed depression (25) and an internal screw threading to create the morse taper, and a female assembly that accepts the acetabulum (21) functionally extending into the concave space); an outer peripheral sidewall that flares out to seamlessly continue with the concave surface (10) (see Figs. 2 and 4 illustrating the concave surface of the acetabular base (10), an outer spherical sidewall of the base (10) flaring outward from the central apex and a seamless continuation of the base (10) which is a unitary integral element acting as a single spherical segment). Loffredo fails to disclose an acetabular ball firmly attached to said peg, the peg being configured to lock within said female Morse taper early enough to prevent the acetabular ball from making direct contact with the outer peripheral sidewall or the concave surface of the unitary acetabular cup; a femoral cup to be firmly affixed to a proximal end of a femoral implant; and a handheld compactor.
Katrana et al. also discloses the modular connection of the male-on-ball and female-on-cup Morse taper orientation. Katrana et al. teaches a glenosphere (12) is firmly attached to a coupling taper configured to mate with an internal taper, inherently achieving an interference fit what creates a gap that allows the humeral cup that is affixed to the proximal end of a stem, allowing it to move freely without hitting the outer peripheral sidewall (see Col. 3, lines 36-45; Col. 4, line 4-15; Col. 5, lines 27-32 disclosing articulating components (12), a coupling taper (44), a metallic cup (14) having a central bore (20) acting as the female Morse taper interface, a selected taper length which allows the articulating component (12) to be secured to the metallic cup (14) before the base of the head (18) contacts the rim of the base, and the cup (14) functioning as the femoral cup to articulate with the head (18) and ultimately affixed to the humeral stem (12) functioning as the femoral implant in order to have a modular connection which inherently requires a specific axial impact from a handheld compactor to seat the components together). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have included Loffredo’s ability to have a central opening in the cup for optimal screw trajectory, wherein a female Morse taper geometry is used to pass through the central opening in a cup of a shoulder implant as taught by Katrana et al. Doing so would provide a means to have a modular, bone-preserving reverse hip replacement system that specifically avoids mechanical interference between components and reduce implant weight.
Regarding claim(s) 15-16, Loffredo in view of Katrana et al., discloses the reverse hip prosthesis system of claim 14, but fails to disclose the concave surface of the acetabular cup is hemispherical; and the convex surface of the acetabular cup is hemispherical.
Katrana et al. also discloses geometric configurations of the reverse joint system as having concave and convex surfaces. Katrana et al. teaches the metallic cup (14) has a concave internal surface configured to articulate with the polymeric cover of the head (18) and a convex outer surface intended for mounting into bone, inherently creating the hemispherical nature implied by the function of the cup (14) (see Figs. 1, 2A and 3 illustrating the hemispherical geometries). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have Loffredo’s acetabular cup of a reverse hip implant, wherein a metallic cup can have a concave inner surface and convex outer surface that is hemispherical as taught by Katrana et al. Doing so would provide a means have a modular reverse hip system where the hemispherical surfaces provides the best possible “nesting” for both the bone (externally) and the modular ball assembly (internally).
Regarding claim 17, Loffredo in view of Katrana et al., discloses the reverse hip prosthesis system according to claim 14, but fails to disclose the inner circular wall height, measured from the narrow end to the larger end, does not to exceed one and half the diameter of the larger end central opening.
Katrana et al. also discloses a Morse taper geometry with standard taper proportions and a “Stubby” design. Katrana et al. teaches the Morse taper as being naturally shallow to ensure it does not take up too much vertical space within the bone, as the cup (14) must fit within the thin bone, through an opening (20) at the proximal end of the stem that cannot be overly deep, which inherently creates a diameter that cannot exceed the height of the opening in order to prevent penetration through the back of the implant (see Figs. 4 and 5A illustrating proportional scaling of the opening (20) as being significantly shorter than the diameter of the larger end). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have Loffredo’s acetabular cup of a reverse hip implant, wherein a shoulder taper maintains a shallow taper ratio to achieve contact prevention as taught by Katrana et al. Doing so would provide a means for ensuring mechanical stability and structural integrity while maintaining a low-profile geometry necessary for a bone-preserving reverse hip implant.
Regarding claim(s) 18-20, Loffredo in view of Katrana et al., discloses the reverse hip prosthesis system according to claim 14, but fails to disclose the unitary acetabular cup provides at least two or more recesses configured for receiving fixation pins from said handheld impactor; at least two or more recesses are diametrically opposed and are located close to the equatorial edge of the cup; and the two or more diametrically opposed recesses are circular pinholes, oblong, or polygonal in shape.
Katrana et al. also discloses recesses for fixation and impacting on the stationary metallic cup (14) for secure attachment to bone. Katrana et al. teaches one or more mounting posts (32) can take the form of fixation pegs or screws, a structural opening (20) at the proximal end of the stem that serves as the engagement point for impactors to drive the component into the bone, and pinholes that are generally circular, and anti-rotation tabs (52) that are non-circular (see Col. 4, lines 1-5, lines 50-57; and Figs. 1 and 2A disclosing mounting posts (32) which are generally circular or cylindrical and associated holes functionally similar to recesses; an equatorial edge located on the outer portion of the base (48); tabs (52) that can have other non-circular surfaces (e.g., oblong, or polygonal); and diametrically opposed peripheral features of the mounting posts (32)). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have Loffredo’s acetabular cup of a reverse hip implant, wherein multiple peripheral fixation points are arranged in a balanced circular arrangement to secure the hemispherical cup (14) as taught by Katrana et al. Doing so would provide a means for precise mechanical orientation and anti-rotational stability during the critical impaction phase of surgery.
Regarding claim 26, Loffredo in view of Katrana et al., discloses the reverse hip prosthesis system of claim 14, but fails to disclose the acetabular ball firmly attached to the peg is a monoblock, or wherein the acetabular ball is firmly attached to the central post via a Morse taper.
Katrana et al. also discloses modularity and material composition of the articulating head (18) to allow for customization. Katrana et al. teaches a polymeric cover (42) acting as the ball; a metallic substrate (40) with a retention flange (50) and an anti-rotation tab (52) to prevent separation or rotation; a coupling taper (44) with angled sidewalls (46) to receive a taper adaptor (16) via a Morse taper, and is connected to the substrate (40) to provide the structural equivalent of the peg (see Col. 4, lines 40-65 disclosing the head (18) and its components that form the equivalent of an acetabular ball, a peg formed by the coupling taper a monoblock formed by the molded assembly of the cover (42) and metallic substrate (40) and the Morse taper lock interface). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided Loffredo’s unitary cup and apex access, wherein an internal Morse taper secures the head to the cup or stem as taught by Katrana et al. Doing so would provide a means for customizing the mechanical rigidity vs the modular adjustability of the reverse hip joint.
Claim(s) 22-25 are rejected under 35 U.S.C. 103 as being unpatentable over Loffredo (US 2017/0035571) as applied to claim 14 above, in view of Katrana et al. (US 8246687) and further in view of Padget et al. (US 9339286).
Regarding claim(s) 22-25, Loffredo, in view of Katrana et al., discloses the reverse hip prosthesis system of claim 21, but fails to disclose a handheld impactor comprises: a metallic sleeve; mounted on a central shaft, the shaft providing a handle at its proximal end; a spring mounted on said central metallic core for distally biasing said metallic sleeve; and a frustum for preventing contact with a central Morse extension during impaction, said polyethylene frustum having at least two or more diametrically spring-loaded fixation pins; the distal end of said metallic sleeve is tapered in order to provide a cam action which extends the fixation pins outwardly into the diametrically opposed recesses of the unitary acetabular cup; fixation pins are located in diametrically opposed cylindrical channels and pushed inwardly via springs; and springs are coil springs.
Padget et al. also discloses a mechanical assembly for a multi-layered shaft (20) assembly (see Col. 5, lines 63-67 disclosing the medical device portion (10) which includes the shaft (20)). Padget et al. teaches an outer articulating shaft (20) with metallic slats (31) acting as sleeves; a proximal handle assembly (46) with the handle structure at the proximal end; actuators (80) and tension members providing force along the longitudinal axis, thereby having the structural equivalent to a distally biased spring on a central core; pivot members (26) and pins (28), housed within pin holes (257 and 263) that inherently form cylindrical channels and are actuated by movement of the shaft (20), thereby creating a cam action which causes rotational or outward extension of the pins (28); and an inner passageway which can inherently act as site for a polyethylene frustrum to protect the Morse extension (peg) of the implant, and is configured to receive an actuator (80), which is routinely coupled with coil springs as standard biasing elements to provide a return force (see Col. 2, lines 35-40; Col. 6, lines 6-23, lines 36-40; Col. 11, lines 1-8 disclosing the slats can be made of any material (e.g., medical grade stainless steel), a proximal handle, cam-action created by pins in pin holes, and an inner passageway that can accommodate a flexible tube or other delivery components). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the unitary acetabular cup of Loffredo, as modified by Katrana et al., with the mechanical blueprint for the specialized hand-held compactor with the cam-action pin assembly as taught by Padget et al. Doing so would provide a means for high-precision, automated engagement and protection of modular orthopedic components during surgical implantation.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEFAN BRADLEY CAMPBELL whose telephone number is (571)272-3498. The examiner can normally be reached Monday - Friday 7:30am-5:00pm.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/STEFAN BRADLEY CAMPBELL/Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799