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
Claims 3-5, 8, 16 are objected to because of the following informalities:
Claim 3 is objected to for referring to “a first scallop” when it is unclear how, if at all, this relates to the previously claimed “plurality of scallops”.
Claim 4 is objected to for referring to “a second scallop” when it is unclear how, if at all, this relates to the previously claimed “plurality of scallops”.
Claim 5 is objected to for referring to “the body” with improper antecedent basis.
Claim 8 is objected to for appearing to miss a word between “wherein” and “articular component”.
Claim 16 is objected to for referring to “a humerus” when it is unclear how, if at all, this relates to the previously claimed “proximal humerus”.
Appropriate correction is required.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “prosthesis body” with its “first superior surface”, “anterior surface”, “posterior surface”, the prosthesis body includes a midline plane bisecting it and extending in a superior-inferior direction and a medial-lateral direction, must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
The drawings are objected to because:
-items 812, 840 are both used in the figures to represent “indicia”
-items 910 and 912 are both used in the figures to represent “locking arm”
-item 912 is used to represent both “cam/sliding member and locking arm”
-item 110 is used to represent both “proximal body” and “prosthesis body”, and “stem”
-item 116 is used to represent both “second proximal surface” and “second superior surface”
-items 130, 132are both used in the figures to represent “stem”
-item 145 is used to represent both “main body” and “adapter body”
-item 148 is used to represent “tapered bore”, “central bore”, “adapter”, and “narrower bore”
-item 151a is used to represent both “first portion” and “implant spacers”
-item 151b is used to represent both “second portion” and “through bores”
-item 153 is used to represent both “suture openings “ and “proximal humorous”
-item 152a is used to represent both “first suture opening” and “first porous ring”
-item 156 and i153a are used to represent “porous rings”
-item 156b represents “second suture opening” and “second suture ring” and “porous ring”
-item 206c represents both “third scallop” and “second scallop”
-item 208 represents both “opening” and “scallops”
-item 2112 represents both “proximal portion” and “metaphyseal portion”
-item 233 represents both “convex articular surface” and “connection side”
-items 232, 233 both represent “connection side”
-item 260 represents “articular component”, “Reverse insert tray”, “reverse articular component”
-item 262, 260 both represent “inverse tray”
-item 317 represents both “pockets” and “porous patches”
-item 117 and 317 both represent “porous patches”
-item 321 represents both “first bone” and “scalloped opening”
-item 347 represents “protrusions”, “presses flexures”, and “shoulders”
-item 422 represents “interior surface”, “guide surface”, and “proximal guide surface”
-item 52 represents both “humeral shaft” and “bone”
-item 700, 710, and 720 all represent the inserter/extractor handle
-item 700 represents both “inserter/extractor handle” and “handle assembly”
-item 720 represents both “connector” and “handle”
-item 740 represents “first portion”, “connector body”, “main body”
-item 810 represents both the main body/scale, and trial proximal body
-item 812 is used to represent both “face” and “indicia”
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 12 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 pre-AIA the applicant regards as the invention.
Claim 12 is indefinite for claiming the system “further comprises a trialing adapter”, that adapter having a connection portion with flange that has an opening that “at least partially defin[es] the first bore of the prosthesis body”, but this is unclear. Claim 1 has defined the system as already including “a prosthesis body”, making it unclear how a component distinct from the prosthesis body (e.g. the trialing adapter) can define a bore that belongs to the distinct element (the prosthesis body). It is unclear how limitations of claims 1 and 12 can be met at the same time.
The claim also states that the connection portion (of the trialing adapter) is received within the second bore (of the prosthesis body), which appears to now indicate that the two elements are distinct, which makes this further unclear.
However, the claim then states that the scallops (presumably of the “first bore” of the prosthesis body), “are disposed within the flange about the opening”, when the flange/opening appear to be part of the trialing adapter. The Examiner is unclear on the relationship between all these elements based on the language of the claim. Since the language of both claims 1 and 12 appear to not be able to be met at the same time, the Examiner is unclear on how to reject claim 12 with prior art. If clarification is provided, the Examiner may yet apply prior art.
Remaining claims are rejected for depending on a rejected claim.
Claim Rejections - 35 USC § 103
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 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 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-11, 13, 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Emerick et al. (US 20160278945 A1) hereinafter known as Emerick in view of Knox et al. (US 20210228372 A1) hereinafter known as Knox.
Regarding claim 1 Emerick discloses a system for replacing a proximal humerus (Abstract) comprising:
a prosthesis body (Figure 8a-b item 150) having a first superior surface (Figure 8a item 190), an anterior surface (Figure 8a, front surface below item 186), a posterior surface (Figure 8a rear surface by item 154), a lateral surface and a medial surface (Figure 8a, considered to be the side surfaces that connect the anterior, posterior, superior 190, and inferior 194 surfaces), and a first bore extending through the first superior surface (Figure 8a item 166),
and an articular component having a body ([0062] articular component) and a boss extending therefrom ([0062] the articular component includes a corresponding feature to engage threadingly with section 174 of the first lumen 166, which is considered to be a boss in order to engage properly with 174), the body having an articular surface disposed thereon ([0062] an articular component is considered by definition, to have an articular surface), and the boss being configured to be received within the first bore ([0062])
but is silent with regards to the first bore including a plurality of scallops arrayed about the central axis, and the boss having a protrusion extending radially outward therefrom to engage one of the scallops.
However, regarding claim 1 Knox teaches an implantable bone system that includes a prosthesis body having a bore (Figure 3 item 104) with a plurality of scallops about a central axis thereof (Figures 3-4, shows scallops 244 within the bore), and
a second component intended to connect thereto (Figure 3 item 108) that includes a protrusion extending radially outward therefrom and being configured to engage one of the scallops (Figures 3-4 item 234). Emerick and Knox are involved in the same field of endeavor, namely bone implants. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the system of Emerick so that the first bore includes scallops that engage with a second component’s protrusion as is taught by Knox in order to ensure the two prosthetic parts can engage with one another at any of a variety of desired, approved angles, and preventing rotation thereafter, thus allowing the implanting physician precise control over the angle but having the resulting prosthesis not in ranger of loosening.
Regarding claim 2 the Emerick Knox Combination teaches the system of claim 1 substantially as is claimed,
wherein Emerick further discloses the prosthesis body includes a midline plane bisecting it and extending in a superior-inferior direction and a medial-lateral direction (Figure 8a a midline plane is considered able to extend in both directions),
and wherein Knox further teaches an articular component body (Figure 1a item 800) with a central axis (Figure 1a) and the boss (Figure 1g item 74) defines a boss axis (Figure 1g item 72) which is offset from the central axis (Figure 1g item 70). It would have been obvious to one of ordinary skill at the time the invention was filed to modify the articular component so it includes an off-center axis as is taught by Knox in order to allow the implanting physician flexibility to adjust the location of the articular surface to a preferred placement ([0111]).
Regarding claim 3 the Emerick Knox Combination teaches the system of claim 2 substantially as is claimed,
wherein Knox further teaches the articular component has a first eccentricity configuration relative to the prosthesis body in which the protrusion engages a first scallop ([0160]) and
wherein the Combination further teaches the central axis of the component body and the boss axis are coplanar with the midline plane (when Emerick is modified to have its articular component/prosthesis body include the scalloped coupling, the central axis of the component and boss of the articular component attached thereto are coplanar with the midline at point +0 (seen in Knox Figure 4)).
Regarding claim 4 the Emerick Knox Combination teaches the system of claim 3 substantially as is claimed,
wherein Knox further teaches the articular component has a second eccentricity configuration relative to the prosthesis body in which the protrusion engages a second scallop (Figure 4 shows all the sites available; [0160]) and
wherein the Combination further teaches the boss axis is coplanar with the midline plane and the central axis of the component body is offset in the anterior or posterior direction relative to the midline plane (when Emerick is modified to have its articular component/prosthesis body include the scalloped coupling, the central axis of the component and boss of the articular component attached thereto would be offset in the anterior or posterior direction relative to the midline at point +1, +2, or +3 (seen in Knox Figure 4)).
Regarding claim 5 the Emerick Knox Combination teaches the system of claim 4 substantially as is claimed,
wherein Knox further teaches the articular component body includes a central opening coaxial with the central axis of the body (Figure 1b item 844) and a through-bore extending through the articular component body (Figure 1b item 844) and boss (Figure 19c shows the body of the articular component including a through-bore through the boss), the through-bore being coaxial with the boss axis (Figure 19c).
Regarding claim 6 the Emerick Knox Combination teaches the system of claim 4 substantially as is claimed,
wherein the Combination further teaches the articular surface is a concave articular surface (Emerick [0005] reverse shoulder prostheses can be provided which includes a spherical surface being secured to the glenoid and the articular component that interacts therewith is complementary to the glenosphere; Knox teaches a reverse prosthesis that interacts with a glenoid surface is concave ([0105])).
Regarding claim 7 the Emerick Knox Combination teaches the system of claim 4 substantially as is claimed,
wherein the Combination further teaches the articular surface is a convex articular surface (Emerick [0004] a typical articular component articulates with the native glenoid socket; Knox shows the articular surface can be convex to articulate with a glenoid (Figure 1a item 804, [0188])).
Regarding claim 8 the Emerick Knox Combination teaches the system of claim 2 substantially as is claimed,
wherein Emerick further discloses the articular component includes a reverse trial insert ([0005] reverse shoulder prostheses can be provided which includes a spherical surface being secured to the glenoid and the articular component that interacts therewith is complementary to the glenosphere) having a concave articular surface (Knox [0105]), and
wherein Knox further teaches the component body is a tray (Figure 1b item 830) having an inner surface (Figure 1b item 840) bounded by a rim (Figure 1b item 832) such that the rim and inner surface together define a cavity configured to receive the reverse trial insert (Figure 1b item 800a).
Regarding claim 9 the Emerick Knox Combination teaches the system of claim 2 substantially as is claimed,
wherein Knox further teaches the articular component includes a humeral trial head (Figure 5 item 126) having a convex articular surface (Figure 5; [0118]), and a socket disposed opposite the convex articular surface (Figure 5 item 223), and wherein the articular component body is configured to be received within the socket of the humeral head trial (Figure 5 shows a component body 200 within the head 126).
Regarding claim 10 the Emerick Knox Combination teaches the system of claim 9 substantially as is claimed,
but is silent with regards to the articular component body including an axial slot, and the articular component includes a rib disposed within the socket, the rib being configured to be received within the axial slot of the component body.
However, regarding claim 10 Knox teaches an articular component body (Figure 16a item 924) which includes an axial rib (944), and an articular component (Figure 16a item 904) which includes an axial slot (Figure 16a item 920), the rib being configured to be received within the axial slot ([0118]). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the system of the Emerick Knox Combination to switch the locations of the rib and slot so that the component body includes the slot and the articular component includes the rib since this since it has been held that rearranging parts of a prior art structure involves only routine skill in the art. See MPEP 2144.04(VI)(C).
Regarding claim 11 the Emerick Knox Combination teaches the system of claim 1 substantially as is claimed,
wherein Emerick further discloses the prosthesis body includes a second bore extending entirely therethrough (Figure 8b item 170).
Regarding claim 13 the Emerick Knox Combination teaches the system of claim 1 substantially as is claimed,
wherein Emerick further discloses the anterior and posterior surfaces are each planar (“planar” is defined by Merriam-Webster as “of, relating to, or lying in a plane”. The Examiner understands all the surfaces of a three-dimensional object to relate to or lie within a plane.) and each intersect the first superior surface, the lateral surface, and the medial surface (see the rejection to claim 1 above where the surfaces are described this same way, along with Figure 8a which shows the surfaces intersecting),
but is silent with regards to the lateral surface having a spherical curvature.
However, referring to Figure 7b of Emerick, it is clear that the metaphyseal portions of Emerick have a spherical curvature, at least towards the inferior surface shown in detail in Figure 7b. The person of ordinary skill would have found it obvious at the time the invention was filed to modify the system of the Combination so the lateral surface of the prosthesis body likewise has a spherical curvature near the inferior end as is shown, since this type of configuration is believed to be understood or at least obvious in light of the various figures/embodiments of Emerick.
Regarding claim 16 the Emerick Knox Combination teaches the system of claim 13 substantially as is claimed,
wherein Emerick further discloses a stem component having a stem (Figure 3 item 14) and adapter (Figure 3 item 34), the stem being configured to be received within an intramedullary canal of the humerus (This is stated as an “intended use” of the claimed device. The applicant is advised that a recitation of the intended use of an invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2111.02 (II). In this case, the patented structure of Emerick was considered capable of performing the cited intended use of being inserted in an intramedullary canal, if desired. See also the Abstract, [0004]).
Claims 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Emerick and Knox as is applied above in view of Chavarria et al. (US 20160206436 A1) hereinafter known as Chavarria.
Regarding claim 14 the Emerick Knox Combination teaches the system of claim 13 substantially as is claimed,
but is silent with regards to the prosthesis body including two suture openings.
However, regarding claim 14 Chavarria teaches a bone prosthesis system in which a prosthesis body includes a first and second suture opening (Figure 8, items 78, 76, 74, etc.) which each define an axis (Figure 8), and wherein the axes intersect (Figure 8 shows how the axes are not co-axial). Emerick and Chavarria are involved in the same field of endeavor, namely prosthetic systems. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the system of the Emerick Knox Combination so that there are suture holes as is taught by Chavarria in order to provide openings into which can assist in suturing soft tissues to the implant system.
Regarding claim 15 the Emerick Knox Chavarria Combination teaches the system of claim 14 substantially as is claimed,
wherein Chavarria further teaches the anterior surface includes a porous patch (Figure 8 item 22; [0040]) and one of the suture opening axes overlaps the porous patch (Figure 8 shows how at least one of the axes of the sutures overlaps with the porous material seen in the figure at least from one view/perspective/orientation). It would have been obvious to one of ordinary skill to have the surfaces of the system coated in a porous patch as is taught by Chavarria in order to promote bone ingrowth for permanent fixation ([0040]).
Claim 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Emerick and Knox as is applied above in view of Doubler et al. (US 20080140210 A1) hereinafter known as Doubler.
Regarding claim 17 the Emerick Knox Combination teaches the system of claim 16 substantially as is claimed,
but is silent with regards to the adapter having a radially protruding collar with a distal porous surface.
However, regarding claim 17 Doubler teaches a prosthetic system with a stem adapter having a radially protruding collar (Figure 17-18 show the stem 12 which has a flared collar at the proximal end) having a distal porous surface (the flared proximal end of the stem 12 includes flutes 16 which are considered elongate pores). Emerick and Doubler are involved in the same field of endeavor, namely bone prosthesis systems. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the system of the Emerick Knox Combination so that the stem has an adapter with a collar and porous surface as is taught by Doubler since it has been held by the courts that a change in shape or configuration, without any criticality in operation of the device, is nothing more than one of numerous shapes that one of ordinary skill in the art will find obvious to provide based on the suitability for the intended final application. See MPEP 2144.04 (IV)(B). It appears that the disclosed device would perform equally well shaped as disclosed by Emerick.
Claim 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Emerick and Knox as is applied above in view of Maale (US 20160296337 A1).
Regarding claim 18 the Emerick Knox Combination teaches the system of claim 16 substantially as is claimed,
wherein Emerick further discloses a spacer (Figure 3 item 18) connectable to the proximal body and adapter (Figure 3),
the spacer having a first ring (Figures 2-4 item 18),
but is silent with regards to the ring being porous, and having first and second suture openings.
However, regarding claim 18 Maale teaches wherein a spacer can have a porous ring therearound (Figure 8 item 808; [0042]) and can include first and second suture openings (Figure 8 item 806; [0042]), wherein the first spacer suture opening is disposed superior and adjacent the first porous ring and the second spacer suture opening is disposed inferior and adjacent the first porous ring (Figure 8 shows at least one suture opening 806 that lies above and below the center suture ring 808). Emerick and Maale are involved in the same field of endeavor, namely bone implant systems. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the system of the Emerick Knox Combination so that the spacer is porous and has suture openings as is taught by Maale in order to encourage bone ingrowth to encourage permanent fixation and provide openings for suture attachment to likewise encourage attachment.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jacqueline Woznicki whose telephone number is (571)270-5603. The examiner can normally be reached M-Th 10am-6pm EST.
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, Jerrah Edwards can be reached on 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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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774
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