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 . Claims 1, 2, 4, 5, 7-9, 11-13, 16, 18, 19, 21, 22, 24-26, 28, 31, and 53 are pending and examined below.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: the interiorly facing engagement means in claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof:
the interiorly facing engagement means are interpreted to be a ring protrusion 518A
snapping into a channel 529 according to paragraph [0055] of the specification (see PG Pub US 2024/0398577).
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claims 21 and 22 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.
Claim 21 recites the limitation "said ledge" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 22, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 102
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.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, 7, 8, 16, and 53 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2020/051595 A1 (Longobardi).
Regarding claim 1, Longobardi discloses a modular humeral component (humeral head 400, see Fig. 5A) for use in a modular shoulder prosthesis system (see Abstract and Fig. 5A for system) having a shoulder base (humeral stem 500, see Fig. 5A) with or without notches and/or attachment points ( the modular component includes a pair of flanges extending from opposing sides of the modular component, the flanges configured to align with the notches when the modular component is attached to the base, see [0021]), the modular humeral component comprising:
an inner head (inner head 418, see Fig. 4B) having
a base (base 410, see Fig. 4B),
a dome on said base (see dome shape on upper surface of inner head 418 in Fig.
4B), and
an optional plug extending away from said base (plug 420 extending from lower
surface of inner head 418, see Fig. 4B); and
a shell configured to fit over said inner head (outer shell 419 configured to fit over inner head 418, see Fig, 4B), said shell having
a body having an exterior surface (exterior convex surface of outer shell 419,
see Figs. 4B and 5A) configured for engagement with a concave surface of a glenoid component (designed to fit into concave surface 211 of modular glenoid component 200, see Fig. 5A), said body defining an interior cavity configured to receive said dome (outer shell 419 with body defines an interior cavity and fitted over inner head 418, see Fig. 4B), and
an interiorly facing engagement means for attachment of said shell to said inner head (as interpreted under 112(f) above, humeral head 400 includes an outer shell 419 that is pressed over an inner head 418 of a base 410… outer shell 419 is configured to slide relative to the inner head 418, see [0070] and Fig. 4B; the press-fit engagement is an equivalent structure because it performs the identical claimed function in substantially the same way to achieve substantially the same result) where said engagement means is in the interior cavity (see Fig. 4B).
Regarding claim 2, Longobardi further discloses wherein said shell fits over the shoulder base (outer shell 419 fitted over humeral stem 500, see Fig. 5A) and an inner diameter of an opening of the interior cavity is slightly larger than a diameter of the shoulder base (see Annotated Fig. 5A) and/or
wherein said shell includes an outer lower edge that is beveled, convex, or arcuate-shaped (outer shell 419 is a hemi-spherical dome, which has a convex, arcuate outer surface continuous to its lower edge, see [0070] and Fig. 4B).
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Regarding claim 7, Longobardi further discloses wherein said inner head includes cobalt-chromium and said shell includes a high-density polyethylene (inner head 418 includes Co—Cr (cobalt-chromium) and the outer shell includes a high-density polyethylene, see [0024] and [0071]).
Regarding claim 8, Longobardi further discloses wherein said inner head includes Ti6Al4V, a titanium-aluminum alloy, or cobalt-chromium (inner head 418 includes Co—Cr, see [0024] and [0071]).
Regarding claim 16, Longobardi further discloses the second alternative wherein said inner cavity (outer shell 419 with body defines an interior cavity, see Fig. 4B) includes a semi-spherical section configured to receive said dome of said inner head (outer shell 419 is a hemi-spherical cap defining a hemi-spherical cavity that receives the dome of inner head 418, see Fig. 4B) where said semi-spherical section is interior to said engagement means (outer shell 419 define a hemi-spherical cavity or section that is interior to the press-fit engagement at the interface between outer shell 419 ad inner head 418, see Fig. 4B).
Regarding claim 53, Longobardi discloses a modular shoulder prosthesis system (see Abstract) comprising:
a humeral stem (humeral stem 500, see Fig. 5A) having a mounting surface (see Annotated Fig. 5A below) into which a receiving cavity extends (cavity 520 extends inward from the mounting surface, see Annotated Fig. 5A below); and
a central stem extending from said mounting surface (centrally located plug 420
extends from mounting surface, see Annotated Fig. 5A below and [0072]);
said modular component according to claim 1 (Longobardi discloses the modular
component of claim 1, see claim 1 above) configured to be removably attached to said mounting surface (plug 420 of the humeral component is received in cavity 520 of the humeral stem 500 via a reverse Morse taper stem, and thus it is removably attached to the mounting surface, see [0075]), and
wherein said humeral stem (humeral stem 500, see Figs. 5A and 5B) is capable of attachment to different modular components (humeral stem 500 capable of attachment to modular components humeral head 400 and humeral cup 600) to facilitate both traditional anatomic total shoulder replacement (humeral stem 500 attachment to humeral head 400 in a traditional anatomic total shoulder replacement, see [0073] and Fig. 5A) and reverse total shoulder replacement (humeral stem 500 attachment to humeral cup 600 in a reverse total shoulder replacement, see [0074] and Fig. 5B) with a change in the modular component (humeral stem is designed to remain in place while switching the modular component and the modular humeral component, respectively, to switch from a ta-TSR to a r-TSR, see [0052]).
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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.
Claims 4, 9, 11-13, 18, 19, 22, 24-26, 28, and 31 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2020/051595 A1 (Longobardi) in view of US 2007/0106390 A1 (Richards).
Regarding claim 4, Longobardi further discloses wherein said dome is a hemi-spherical dome (inner head 418 is a hemi-spherical dome, see Fig. 4B) and a surface of said interior cavity of said shell is hemi-spherical (see Fig. 4B),
said shell is configured to slide relative about said dome to allow for dual mobility between said shell and said inner head (humeral head 400 includes an outer shell 419 that is pressed over an inner head 418 of a base 410…the outer shell 419 is configured to slide relative to the inner head 418. In a further embodiment, the outer shell 419 is smaller than an exterior surface of the inner head 418 to provide additional range of dual-mobility, see [0070]) or said shell is configured to freely rotate relative to said inner head (outer shell 419 is configured to slide relative to the inner head 418, see [0070]).
Longobardi does not disclose that the dual mobility between said shell and said inner head is configured such that any pivoting between them is limited by said ledge, however Richards discloses an acetabular prosthesis that can be used in a prosthetic shoulder joint assembly (see Abstract and [0046]), including a groove 42 with a ledge that retains protrusion 43 of cup portion 11 for snap engagement (see Annotated Fig. 8B).
Richards teaches that protrusion 43 mates with groove 42, and that the engagement
allows relative rotation of liner 10 within acetabular shell 60 with respect to central longitudinal axis 20, while preventing relative axial translation (see [0036]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modular humeral component disclosed by Longobardi to include a ledge to prevent any pivoting between the shell and inner head configured for dual mobility, as taught by Richards, in order to allow rotational translation of one component within another while preventing axial translation between them (see [0036] and [0039]).
Regarding claim 9, Longobardi does not disclose wherein said engagement means includes a ring protrusion, however Richards further discloses wherein said engagement means (liner 10 is snap-fitted into cavity 63 of acetabular shell 60, see [0036]) includes a ring protrusion (protrusion 43 that extends circumferentially around cup portion 11, see [0035] and Figs. 8A and 8B) that engages a channel around a peripheral lower edge of said base (protrusion 43 mates with groove 42 in the inner surface 61 at the shell/liner interface 40 and peripheral lower edge of cup portion 11, see [0035], [0036], and Figs. 8A and 8B).
Richards teaches that interface 40 may be constructed of any configuration which
prevents axial translation of liner 10 and acetabular shell 60 while simultaneously allowing rotational translation (see [0039]), including an embodiment where the protrusions are instead radially inwardly-directed on the shell (see [0038]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modular humeral component disclosed by Longobardi to have an engagement means including a ring protrusion with channel engagement, as taught by Richards, in order to allow rotational translation of one component within another while preventing axial translation between them (see [0036] and [0039]). The modification amounts to the simple substitution of one known bearing-retention structure (circumferential snap protrusion-in-groove) for another (press-fit) to obtain the predictable result of a retained, rotatable shell (see MPEP 2143(I)(B)).
Regarding claim 11, Longobardi does not disclose wherein said base further includes a shoulder above said channel and a lower shoulder below said channel, however Richards further discloses wherein said base (peripheral lower edge of cup portion 11, see Fig. 8A) further includes a shoulder above said channel (see Annotated Fig. 8A) and a lower shoulder below said channel (see Annotated Fig. 8A) that together said shoulders define a groove as said channel (groove 42 defined by upper and lower shoulders as a channel around the peripheral lower edge, see Figs. 8A and 8B).
Richards teaches that protrusion 43 mates with groove 42, and the engagement
allows rotation of liner 10 within acetabular shell 60 with respect to central longitudinal axis 20 while preventing relative axial translation (see [0036]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the base of modular humeral component disclosed by Longobardi to include upper and lower shoulders that define a groove, as taught by Richards, in order to provide the walls to secure the components together but prevent relative axial translation.
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Regarding claim 12, Longobardi does not disclose wherein said ring protrusion and said channel have complementary shapes, however Richards further discloses wherein said ring protrusion and said channel have complementary shapes (protrusion 43 mates with groove 42, see [0036]) configured to allow for rotation of said shell relative to said inner head (engagement of protrusion 43 in groove 42 allows rotation of liner 10 within acetabular shell 60 with respect to central longitudinal axis 20, see [0036]).
It would have been obvious to one of ordinary skill in the art before the effective filing
date of the claimed invention to modify the modular humeral component disclosed by Longobardi so that the ring protrusion and channel has complementary shapes that allow for rotation, as taught by Richards, in order to secure the components together while allowing relative rotation but preventing relative axial translation.
Regarding claim 13, Longobardi in view of Richards does not disclose wherein said ring protrusion and said channel have an approximate semi-circular cross-section or a partial elliptical shape, however Richards further discloses that protrusion 43 includes inclined face 44 to facilitate snap insertion (see [0036] and Fig. 8B). Richards teaches that protrusion 43 may take any shape which facilitates insertion (see [0036]).
It would have been obvious to one of ordinary skill in the art before the effective filing
date of the claimed invention to modify the ring protrusion and channel disclosed by Longobardi in view of Richards to have an approximate semi-circular cross-section or partial elliptical shape, because a rounded profile is among a finite set of conventional cross-sectional shapes for snap engagement, provides a gradual introduction of protrusion 43 and eases the deformation process that Richards teaches is desirable (see [0036]), and enables a smooth bearing interface consistent with the relative rotation. The selection of a particular rounded cross-sectional shape is an obvious matter of design choice, absent evidence that the claimed shape is significant or produces unexpected results.
Regarding claim 18, Longobardi does not disclose wherein said engagement means includes a ledge, however Richards further discloses the first alternative wherein said engagement means (liner 10 is snap-fitted into cavity 63 of acetabular shell 60, see [0036]) includes a ledge (groove 42 has a ledge, see Annotated Fig. 8B below) configured to hook over said inner head (ledge at groove 42 hook over and retains protrusion 43 of cup portion 11 for snap engagement, see Fig. 8B and [0036]).
Richards teaches that protrusion 43 mates with groove 42, and that the engagement
allows rotation of liner 10 within acetabular shell 60 with respect to central longitudinal axis 20 while preventing relative axial translation (see [0036]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modular humeral component disclosed by Longobardi to include a ledge configured to hook or a ledge with a top surface beveled, as taught by Richards, in order to allow rotational translation of one component within another while preventing axial translation between them (see [0036] and [0039]). The modification amounts to the simple substitution of one known bearing-retention structure for another to obtain the predictable result of a retained, rotatable shell (see MPEP 2143(I)(B)).
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Regarding claim 19, Longobardi in view of Richards further discloses wherein a bottom exterior edge of said inner head is beveled (protrusion 43 at the bottom exterior edge of cup portion 11 includes inclined face 44, see [0036]).
Longobardi in view of Richards does not disclose that it corresponds to the bevel of said ledge, however Richards further discloses that at the engagement interface between the inner component and an outer shell, the protrusion 43 includes inclined face 44 to facilitate the initial insertion. Richards teaches that it provides a gradual introduction of liner 10 into cavity 63 of acetabular shell and eases the deformation process, thus teaching the function served by beveling the mating surfaces at such an interface (see [0036]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the bottom exterior edge of the inner head disclosed by Longobardi in view of Richards to have a bevel corresponding to the bevel of the ledge. Where an inner head must be inserted past an interiorly facing ledge of the shell, providing the inner head’s bottom exterior edge with a complementary, corresponding bevel is the predictable means of achieving the gradual, ramped introduction and ease of deformation that Richards teaches is desirable at such an interface (see [0036]). The provision of corresponding beveled profiles on two mating snap surfaces is accordingly a predictable use of a known technique to achieve a known result, and is further a matter of obvious design choice absent evidence showing criticality or unexpected results.
Regarding claim 22, Longobardi discloses a modular component (humeral head 400, see Fig. 5A) for use in a modular shoulder prosthesis system (see Abstract and Fig. 5A for system) having a shoulder base, such as a baseplate or a humeral stem (humeral stem 500, see Fig. 5A), with notches and/or attachment points (the modular component includes a pair of flanges extending from opposing sides of the modular component, the flanges configured to align with the notches when the modular component is attached to the base, see [0021]), the modular humeral component comprising:
an inner head (inner head 418, see Fig. 4B) having
a base (base 410, see Fig. 4B), and
a dome on said base (see dome shape on upper surface of inner head 418 in Fig.
4B); and
a shell configured to fit over said inner head (outer shell 419 configured to fit over inner head 418, see Fig, 4B), said outer shell having
a body having a convex surface (exterior convex surface of outer shell 419,
see Figs. 4B and 5A), said body defining an interior cavity configured to receive said dome (outer shell 419 with body defines an interior cavity and fitted over inner head 418, see Fig. 4B).
Longobardi does not disclose an interiorly facing ledge along a bottom of said body and/or a ring protrusion that is parallel to a bottom of said body, however Richards further discloses the first alternative including an interiorly facing ledge along a bottom of said body (groove 42 define a ledge along the interiorly facing bottom of acetabular shell 60, see Fig. 8A and Annotated Fig. 8B above).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the outer shell disclosed by Longobardi to have an interiorly facing ledge along its bottom, as taught by Richards, in order to prevent axial translation of the shell on the inner head while maintaining the relative rotation between them.
Regarding claim 24, Longobardi in view of Richards does not disclose wherein a top surface of said ledge is beveled in a direction of its free edge, however Richards further discloses that a protrusion 43 includes an inclined face 44 angled towards its free edge (see Fig. 8B). Richards teaches that it provides a gradual introduction of protrusion 43 into the mating cavity 63 and eases the deformation process as the parts snap together (see [0036]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ledge disclosed by Longobardi in view of Richards to have a top surface beveled in a direction of its free edge, as taught by Richards, in order to permit the inner head to enter gradually over the ledge during snap insertion without damaging the components. A person of ordinary skill would have provided the same inclined lead-in geometry on the surface of the ledge that first encounters the inner head during assembly to ease the deformation process.
Regarding claim 25, Longobardi in view of Richards further discloses wherein a bottom exterior edge of said inner head base is beveled (protrusion 43 at the bottom exterior edge of cup portion 11 includes inclined face 44, see [0036]).
Longobardi in view of Richards does not disclose that it corresponds to the bevel of said ledge, however Richards further discloses that at the engagement interface between the inner component and an outer shell, the protrusion 43 includes inclined face 44 to facilitate the initial insertion. Richards teaches that it provides a gradual introduction of liner 10 into cavity 63 of acetabular shell and eases the deformation process, thus teaching the function served by beveling the mating surfaces at such an interface (see [0036]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the bottom exterior edge of the inner head disclosed by Longobardi in view of Richards to have a bevel corresponding to the bevel of the ledge. Where an inner head must be inserted past an interiorly facing ledge of the shell, providing the inner head’s bottom exterior edge with a complementary, corresponding bevel is the predictable means of achieving the gradual, ramped introduction and ease of deformation that Richards teaches is desirable at such an interface (see [0036]). Providing a complementary bevel on the ledge merely duplicates the known lead-in geometry on the mating side. Applying a known bevel to both halves of a snap-fit interface is a predictable use of a known technique to achieve a known result, and is further a matter of obvious design choice absent evidence showing criticality or unexpected results.
Regarding claim 26, Longobardi in view of Richards further discloses wherein said inner head (inner head 418, see Longobardi Fig. 4B) includes a plug (plug 420, see Longobardi Fig. 4B) tapered in a direction from said base to its free tip to define a Morse taper (plug of the modular component includes a Morse taper and/or threaded surface for engagement of the baseplate, see Longobardi [0028] and Fig. 4B).
Regarding claim 28, Longobardi further discloses wherein said dome is a hemi-spherical dome (inner head 418 is a hemi-spherical dome, see Fig. 4B) and said interior cavity of said shell is hemi-spherical (outer shell 419 define an interior cavity that is hemi-spherical, see Fig. 4B),
said shell is configured to slide relative about said dome to allow for dual mobility between said shell and said inner head (humeral head 400 includes an outer shell 419 that is pressed over an inner head 418 of a base 410…the outer shell 419 is configured to slide relative to the inner head 418. In a further embodiment, the outer shell 419 is smaller than an exterior surface of the inner head 418 to provide additional range of dual-mobility, see [0070]) or said shell is configured to freely rotate relative to said inner head (outer shell 419 is configured to slide relative to the inner head 418, see [0070]).
Longobardi does not disclose that the dual mobility between said shell and said inner head is configured such that any pivoting between them is limited by said ledge, however Richards further discloses groove 42 with a ledge that retains protrusion 43 of cup portion 11 for snap engagement (see Annotated Fig. 8B below).
Richards teaches that protrusion 43 mates with groove 42, and that the engagement
allows rotation of liner 10 within acetabular shell 60 with respect to central longitudinal axis 20, while preventing relative axial translation (see [0036]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modular humeral component disclosed by Longobardi to include a ledge to prevent any pivoting between the shell and inner head configured for dual mobility, as taught by Richards, in order to allow rotational translation of one component within another while preventing axial translation between them (see [0036] and [0039]).
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Regarding claim 31, Longobardi in view of Richards further discloses wherein said inner head includes cobalt-chromium and said shell includes a high-density polyethylene (inner head 418 includes Co—Cr (cobalt-chromium) and the outer shell includes a high-density polyethylene, see Longobardi [0024] and [0071]).
Claims 5 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2020/051595 A1 (Longobardi).
Regarding claim 5, Longobardi does not disclose wherein said inner head is bonded to said shell, however Longobardi discloses an outer shell 419 that is pressed over an inner head 418 (see [0065]).
However, under MPEP 2144.04-V-B, the making a structure separable is an obvious
matter of design choice in the absence of new or unexpected results, and therefore the claimed limitation is obvious.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the shell and inner head disclosed by Longobardi such that it is bonded, since it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art (see MPEP 2144.04-V-B). Accordingly, a person having ordinary skill in the art would recognize that a bonded inner head and shell will function equally as well as a separable, press-fitted inner head and shell for the humeral head component disclosed in the prior art, and thus this limitation is an obvious matter of design choice.
Regarding claim 21, Longobardi does not disclose wherein after said modular humeral component is installed on the shoulder base, a gap between a free edge of said ledge and the shoulder base is approximately 1 mm, however Longobardi further discloses that the outer shell 419 is configured to slide relative to the inner hear 418 (see [0070]).
Longobardi teaches that the outer shell 419 is removable from the inner head 418 to
facilitate replacement, for example when the outer shell 419 is worn down from biomechanical movement about the shoulder joint (see [0071]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modular humeral component disclosed by Longobardi to have an approximately 1mm gap between a free edge of said ledge and the shoulder base, since discovering the optimum value of a result effective variable involves only routine skill in the art. The motivation for doing so would have been to provide sufficient clearance for the modular humeral component to slide relative to the shoulder base and inner head, and to facilitate replacement of the modular humeral component.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NHA UYEN C NGUYEN whose telephone number is (571)272-3399. The examiner can normally be reached Monday-Friday 8:30-5:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached at (408) 918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/N.C.N./Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774
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