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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed applications, Application Nos. 63/142,344, 63/581,796, and 17/649,142, fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Prior filed applications 63/142,344 and 17/649,142 do not disclose the central longitudinal stem axis and the central longitudinal protrusion axis intersect at a non-zero offset angle, therefore none of the claims are entitled to their earlier filing dates. Prior filed application 63/581,796 does not disclose the features of claims 51-58, 62, 65-67, and 69-71. Accordingly, claims 48-50, 59-61, 63, 64, and 68 have an effective filing date of 9/11/2023 while claims 51-58, 62, 65-67, and 69-71 have an effective filing date of 9/10/2024.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph 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 the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 49, 53-57, 65, 66, 69, and 70 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) 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, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 49, the specification does not disclose a vertical centerplane of the scapular baseplate comprises a central longitudinal protrusion axis and the central longitudinal stem axis. The specification does not use the term “vertical centerplane” and it is unclear what this plane is. The figures do not appear to show any vertical plane that comprises the axes as claimed. Therefore, claim 49 is directed to new matter.
Regarding claims 53-56, 65, and 69, the specification does not disclose “a central surface axis of an arc formed by intersecting the curved scapular mating surface with a vertical centerplane of the scapular baseplate, wherein the central longitudinal stem axis and the central surface axis intersect at a non-zero surface offset angle”. As mentioned above the specification does not use the term “vertical centerplane” and it is unclear what this centerplane is. For instance, from which perspective is the centerplane of the scapular baseplate defined (i.e. a sagittal or front view)? The specification par.76 discloses “In the present context, the “central axis” (162′) refers to an axis that extends from the center of arc (160′) and bisects arc (160″)”. This does not appear to be the same as what is written in claims 53, 65, and 69 therefore claims 53-56, 65, and 69 are directed to new matter.
Regarding claims 57, 66, and 70, the specification does not disclose that the curved scapular mating surface comprises a chord of an arc formed by intersecting the curved scapular mating surface with a vertical centerplane of the scapular baseplate. As discussed above the vertical centerplane is not discussed or shown in the figures. It is unclear how a chord of an arc is “formed by” intersecting the curved scapular mating surface with a vertical centerplane of the scapular baseplate. The only mention of a chord is found in par.76 which states “In further embodiments having a mating surface (119′) that is curved, the curved mating surface (119′) describes a chord, and the chord may be at an angle (not shown) between 5 and 15 degrees from the second side (122′) of the scapular baseplate (102′, 102″). In some embodiments, the angle (not shown) between the second side (122′) of the scapular baseplate (102′, 102″) and the chord is equal to 10 degrees”. Accordingly, claims 57, 66, and 70 are directed to new matter.
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 49, 53-57, 65, 66, 69, and 70 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.
Regarding claim 49, as discussed above, the specification does not use the term “vertical centerplane” and it is unclear what this plane is. Please clarify what a vertical centerplane of the scapular baseplate is and how such a plane can “comprise” the axes claimed.
Regarding claims 53-56, 65, and 69, because the specification does not disclose “a central surface axis of an arc formed by intersecting the curved scapular mating surface with a vertical centerplane of the scapular baseplate, wherein the central longitudinal stem axis and the central surface axis intersect at a non-zero surface offset angle” and does not use the term “vertical centerplane”, it is unclear what this centerplane is and how a central surface axis of an arc is “formed by” intersecting the curved scapular mating surface with a vertical centerplane of the scapular baseplate.
Regarding claims 57, 66, and 70, because the specification does not disclose that the curved scapular mating surface comprises a chord of an arc formed by intersecting the curved scapular mating surface with a vertical centerplane of the scapular baseplate, and the vertical centerplane is not discussed or shown in the figures, it is unclear how a chord of an arc is “formed by” intersecting the curved scapular mating surface with a vertical centerplane of the scapular baseplate.
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 48-50, 53, 59, 61, 63-65, 68, and 69 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pappas et al. US 4,206,517 (hereafter referred to as Pappas; cited in IDS).
Regarding claim 48, Pappas discloses a scapular baseplate 11 of a reverse shoulder prosthesis (fig.1), the scapular baseplate comprising: a scapular stem 23 configured to interface with a scapula bone, the scapular stem comprising a central longitudinal stem axis (fig.3), and a protrusion 27 configured to interface with a glenosphere component 12 of the reverse shoulder prosthesis, the protrusion comprising a central longitudinal protrusion axis (figs. 1-3), wherein: when the scapular baseplate is in an anatomical orientation, the scapular stem is superior to the protrusion, and the central longitudinal stem axis and the central longitudinal protrusion axis intersect at a non-zero offset angle (fig.1 shows the scapular stem 23 superior to the protrusion 27 when implanted, wherein the longitudinal axes of 23 and 27 are not parallel and therefore intersect at a non-zero offset angle).
Regarding claim 49, fig.2 shows the axes of the stems aligned with the axis of the protrusion and a center plane of the baseplate.
Regarding claim 50, see figs. 2 and 3 for the protrusion 27 being normal to the baseplate surface.
Regarding claim 53, see fig.3 for the curved scapular mating surface, and col.3, lines 41-44 which discloses the shape of the curved scapular mating surface closely approximates the curvature of the glenoid surface to which it is attached. While the “central surface axis” is unclear as discussed above under 35 U.S.C 112, for examination the examiner interprets the claim to require that the central longitudinal stem axis is angled with respect to an axis of the curved scapular mating surface. See Pappas fig.3 and col.3, lines 36-37 which show the stem axis is angled at 35 degrees or about 37 degrees.
Regarding claim 59, see the monolithic implant in figs. 2 and 3.
Regarding claim 61, see figs.1-3 for the scapular stem 23 on a first side and the protrusion 27 on a second opposite side.
Regarding claim 63, see figs.2-3 for trunnion 27.
Regarding claims 64 and 68, see the rejection of claim 48 above and glenosphere component 12 comprising an aperture (see fig.5 for the opening of the ball that receives the protrusion), and a humeral component comprising a humeral stem 17 configured to interface with a humeral bone (fig.1) and a humeral cup 13 configured to interface with the glenosphere component 12 (fig.1).
Regarding claims 65 and 69, see fig.3 for the curved scapular mating surface, and col.3, lines 41-44 which discloses the shape of the curved scapular mating surface closely approximates the curvature of the glenoid surface to which it is attached. While the “central surface axis” is unclear as discussed above under 35 U.S.C 112, for examination the examiner interprets the claim to require that the central longitudinal stem axis is angled with respect to an axis of the curved scapular mating surface. See Pappas fig.3 and col.3, lines 36-37 which show the stem axis is angled at 35 degrees or about 37 degrees.
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.
Claims 54 and 55 are rejected under 35 U.S.C. 103 as being unpatentable over Pappas. Pappas discloses the scapular baseplate of claim 53 but does not disclose that the non-zero offset angle is in a range of 10-25 degrees or 17 degrees. Pappas does disclose an angle of 35 degrees (fig.3) and about 37 degrees (col.3, lines 36-37) and 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 angle of Pappas to be 17 degrees since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), MPEP 2144.05 II A).
Claims 48, 49, 51, 52, 59, 60, 61, 63, 64, and 68 are rejected under 35 U.S.C. 103 as being unpatentable over Crep US 3,978,528 (hereafter referred to as Crep) in view of Pappas.
Regarding claims 48, 64, and 68, Crep discloses a reverse shoulder prosthesis (fig.1) comprising: a scapular baseplate 26 comprising: a scapular stem 30 or 32 configured to interface with a scapula bone, the scapular stem comprising a central longitudinal stem axis (fig.1), and a protrusion 28 attached to a glenosphere component 24 of the reverse shoulder prosthesis, the protrusion comprising a central longitudinal protrusion axis (fig.1), wherein: when the scapular baseplate is in an anatomical orientation, the scapular stem is superior to the protrusion, and the central longitudinal stem axis and the central longitudinal protrusion axis intersect at a non-zero offset angle (figs.1 and 6 shows at least stems 30 and 32 are superior and angled with respect to the protrusion), and a humeral component 12 comprising: a humeral stem 18 configured to interface with a humeral bone, and a humeral cup 14 configured to interface with the glenosphere component (fig.1). Crep discloses the invention substantially as claimed, but the protrusion of Crep appears to be fixedly attached to the glenosphere and therefore Crep does not disclose that the protrusion is configured to interface with the glenosphere component, wherein the glenosphere component comprises an aperture configured to interface with the protrusion.
Pappas teaches a reverse shoulder prosthesis, in the same field of endeavor, wherein a baseplate 11 comprises a protrusion 27 configured to interface with a glenosphere component 12, wherein the glenosphere component comprises an aperture (see fig.5 for the opening of the ball that receives the protrusion) configured to interface with the protrusion for the purpose of securing the glenosphere component to the scapular baseplate (col.3, lines 53-56).
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 one-piece baseplate and glenosphere of Crep to be modular as taught by Pappas in order to allow for replacing just the glenosphere as needed and since it has been held that making parts separable for any desirable reason is an obvious extension of prior art teachings (In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961) MPEP V C).
Regarding claim 49, see fig.6 of Crep for at least stem 32 and the protrusion lying on a vertical centerplane of the scapular baseplate.
Regarding claims 51 and 52, see Crep col.3, line 19 for the protrusion being angled 15 degrees with respect to the plate and Crep col.2, lines 26-33 which discloses the stems extend at strategic angles from the fixation plate for the purpose of being adapted for the particular portion of the body. While Crep does not specifically disclose that the non-zero offset angle of the central longitudinal stem axis and the central longitudinal protrusion axis is 7 degrees, it would have been obvious to select the offset angle as 7 degrees since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), MPEP 2144.05 II A).
Regarding claim 59, see Crep fig.1 for a monolithic scapular baseplate.
Regarding claim 60, see stem 30 in Crep fig.1 which has a distal portion superior to a proximal portion.
Regarding claim 61, see Crep fig.1 for the scapular stems 30 and 32 being on an opposite side as the protrusion.
Regarding claim 63, see Pappas figs.2-3 for trunnion 27.
Claims 56, 57, 62, 66, and 70 are rejected under 35 U.S.C. 103 as being unpatentable over Pappas as applied to claims 48, 53, 61, 64, and 68 above, and further in view of Poon et al. US 2022/0395376 (hereafter referred to as Poon; cited in IDS).
Regarding claim 56, Pappas discloses the scapular baseplate of claim 53 as discussed above, but Pappas does not specifically disclose that the curved scapular mating surface comprises a radius in a range of 22 to 30 mm.
Poon teaches a glenoid component, in the same field of endeavor, wherein a curved scapular mating surface 102 comprises a radius in a range of 27 to 30 mm for the purpose of replicating the bone curvature radius of the original glenoid and obtaining a correct seat for the glenoid component (par.82; figs.1-4).
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 curved scapular mating surface of Pappas to have a radius in a range of 27 to 30 mm as taught by Poon in order to replicate the bone curvature radius of the original glenoid and obtain a correct seat for the glenoid component.
Regarding claims 57, 62, 66, and 70, Pappa discloses the scapular baseplate of claims 48 and 64 as discussed above. Pappas discloses the first side comprises a baseplate surface and the protrusion and a second side comprises a curved scapular mating surface comprising a chord of an arc (fig.3). Pappas discloses the invention substantially as claimed but does not disclose that the chord is oriented at an angle in a range of 5 to 15 degrees with respect to the baseplate surface such that the thickness of the baseplate gradually increases from a bottom edge to a top edge of the scapular baseplate.
Poon teaches a glenoid component, in the same field of endeavor, wherein a curved scapular mating surface comprises a chord of an arc, wherein the chord is oriented at an angle in a range of 5 to 15 degrees with respect to a baseplate surface (figs. 4-5), and wherein the thickness of the baseplate gradually increases from a bottom edge to a top edge of the scapular baseplate (figs. 3B-5) for the purpose of re-establishing the correct conformation in the presence of bone deficits of the angular type (par.25).
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 baseplate of Pappas to include the wedge shape taught by Poon wherein the curved scapular mating surface comprises a chord oriented at an angle in a range of 5 to 15 degrees with respect to the baseplate surface and wherein the thickness of the baseplate gradually increases from a bottom edge to a top edge of the scapular baseplate in order to re-establish the correct conformation in the presence of bone deficits of the angular type.
Allowable Subject Matter
Claims 58, 67, and 71 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The prior art does not disclose the protrusion side of the scapular baseplate comprising a second surface recessed from the first surface, wherein when the scapular baseplate is in the anatomical orientation, the second surface is located superior to a horizontal centerplane of the scapular baseplate, and the second surface is configured to increase a range of motion of the reverse shoulder prosthesis. While Pappas shows openings 26 in the first surface (figs. 2-4), these openings do not define a second surface as claimed.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Basamania et al. US 2010/0241235 and Tornier US 2005/0049709 each disclose a superior stem angled upward in the glenoid (Basamania fig.7 and Tornier fig.8). Shultz et al. US 6,364,910 discloses stems can either be angled upward or downward (figs. 7-10).
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/MEGAN Y WOLF/Primary Examiner, Art Unit 3774
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