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 .
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-9, 11-17 and 19 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant's arguments filed 10/30/2025 have been fully considered but they are not persuasive.
Regarding claims 10 and 20, applicant argues Viscardi’s disclosure of holes in a flange does not relate to a stemless implant have a receiving cavity or flange with suture eyelets. However, Viscardi discloses a stemless implant (fig. 6B) with a receiving cavity (230, opening, fig. 6B) and a flange (201, collar, fig. 6B). Further the combination is intended to teach the use of holes for sutures. The articulated rationale stated, “in order to pass one or more sutures through in aid of fiction of an object to the base (¶ [0079, Viscardi).”
Regarding claim 18, applicant argues the trap door of Bachmaier is a separate component and does not function as a movable or removable portion of the base. However, figs. 6-9 clearly show the short stem (410) is moveable and though not explicitly stated is capable of being fully removed.
Claim Status
Claims 5, 8 and 16 have been cancelled.
Claims 1-4, 6-7, 9-15 and 17-26 are examined below.
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.
“A majority of the articular implant is accommodated within the receiving cavity” must be shown or the feature(s) canceled from the claim(s). With regard to the first embodiment (fig. 1) it is not shown how a majority of the articular implant (18A) would be accommodated within the receiving cavity. No new matter should be entered.
“A tapered profile extending from the flange to the floor of the rounded based and is dimensioned to accommodate a substantial portion of the articular implant” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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 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 1-4, 6-7, 9-10 and 21-26 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 1, the drawings and the specification do not support “a majority of the articular implant is accommodated within the receiving cavity” for all embodiments. There is partial support for the second embodiment (fig. 2) as shown in fig. 12. However, the first embodiment (fig. 1) does not appear the majority would be inlayed and the specification does not describe such an orientation. Dependent claims 2-4,6-7, 9-10 and 21-26 are likewise rejected.
Regarding claim 23, the drawings and the specification do not support “the receiving cavity has a tapered profile extending from the flange to the floor of the rounded base.” The specification points to a taper connection in ¶ [00073] and ¶ [00076] however these general teachings are not specific to the tapered profile extending from the flange to the floor of the rounded base.
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 (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 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.
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.
Claim(s) 1-3, 6-7, 9, 11-15, 17, 19, 21 and 23-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Deransart (US 2023/0307918 A1) in view of Knox (US 2019/0175354 A1).
Regarding claim 1, Deransart discloses a humeral implant assembly for an arthroplasty implant system (fig. 3), comprising:
an articular implant (161, articular components, fig. 2A); and
a stemless implant (108C, stemless bowl-shaped humeral anchor, fig. 5A) adapted to establish a convertible platform for receiving the articular implant (¶ [0089]);
wherein the stemless implant includes a flange (244C, collar, fig. 5A) sized to engage a cortical rim of the bone (¶ [0101]), and a receiving cavity adapted to receive the articular implant (216C and 217C, first and second cavities, fig. 5C)
wherein the receiving cavity extends inwardly from the flange to a floor of a rounded base of the stemless implant (see annotated fig. 5C, below) and is sized to provide an inlay design in which a majority of the articular implant is accommodated within the receiving cavity (For the anatomical replacement (fig. 5C) the coupler 168C and the articular component 160A make up the articular implant. For the reverse replacement the articular component 180A, the reverse articular body 184A would be above the flange, the majority of the body from 185A to 181A would be within the receiving cavity.).
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Deransart fails to teach a thread configured to engage bone. However, Knox discloses a stemless shoulder implant that includes a thread (224, helical structure, fig. 3A) configured to engage a bone (¶ [0056]). The phrase “the thread is configured to engage a bone” is a functional recitation (see MPEP 2114.II). The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing [or being manipulated to] the recited function in order to meet the claim requirements. In this case, the helical structure (224, fig. 3A) is considered to be capable of engaging a bone. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the stemless implant of Deransart to include a thread provided on the cylindrical shaped body as taught by Knox since it is combining prior art elements according to known methods to yield predictable results, which courts have recognized supports a conclusion of obviousness (see MPEP 2143).
Regarding claim 2, Deransart further discloses the articular implant includes a spacer that is coupled to the stemless implant (see annotated fig. 4I, below) and a liner that is coupled to the spacer (see annotated fig. 4I, below), and further wherein the liner includes a concave articular surface (CV, concave surface, fig. 4I).
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Regarding claim 3, Deransart further discloses the spacer is coupled to the stemless implant by a C-clip (183A, snap ring, figs. 4H and 4K).
Regarding claim 6, Deransart further discloses the floor establishes an inner surface of the rounded base (fig. 5C).
Regarding claim 7, Deransart fails to teach the thread is circumferentially disposed about a radially outer surface of the stemless implant. However, Knox discloses a stemless shoulder implant that includes the thread is circumferentially disposed about a radially outer surface of a cylindrical shaped body of the stemless implant (fig. 3A), and wherein an outer diameter of the flange is greater than an outer diameter of the cylindrical shaped body at a tip of the thread (see annotated fig. 3A, below). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the stemless implant of Deransart to include the thread is circumferentially disposed about a radially outer surface of the stemless implant as taught by Knox since it is combining prior art elements according to known methods to yield predictable results, which courts have recognized supports a conclusion of obviousness (see MPEP 2143).
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Regarding claim 9, Deransart further discloses the cylindrical shaped body includes a plurality of pockets adapted to facilitate bony ingrowth (272B, porous surface, [0107]).
Regarding claim 11, Deransart discloses an arthroplasty implant system (fig. 3), comprising:
a cup (108C, stemless bowl-shaped humeral anchor, fig. 5A) including a cylindrical shaped body (fig. 5C), a flange (244C, collar, fig. 5A) a rounded base (see annotated fig. 5C, below), and a receiving cavity (216C and 217C, first and second cavities, fig. 5C),
wherein the flange is sized to engage a cortical rim of the bone (¶ [0101]); and
an articular implant (160A, anatomic articular component or 180A, reverse articular component, fig. 2A)received within the receiving cavity (fig. 5E),
wherein the receiving cavity extends inwardly from the flange to a floor of a rounded base of the stemless implant (see annotated fig. 5C, below) and is sized to provide an inlay design in which a majority of the articular implant is accommodated within the receiving cavity (fig. 5E).
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Deransart fails to teach a thread provided on the cup. However, Knox discloses a stemless shoulder implant that includes a threaded cup (224, helical structure, fig. 3A) including a thread provided on the cylindrical shaped body (fig. 3A), wherein the thread is configured to engage a bone (¶ [0056]). The phrase “the thread is configured to engage a bone” is a functional recitation (see MPEP 2114.II). The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing [or being manipulated to] the recited function in order to meet the claim requirements. In this case, the helical structure (224, fig. 2) is considered to be capable of engaging a bone. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the stemless implant of Deransart to include a thread provided on the cylindrical shaped body as taught by Knox since it is combining prior art elements according to known methods to yield predictable results, which courts have recognized supports a conclusion of obviousness (see MPEP 2143).
Regarding claim 12, Deransart further discloses the flange is integrally formed with the cylindrical shaped body to establish a unitary single piece design of the threaded cup (fig. 5A).
Regarding claim 13, Deransart further discloses a convertible platform for receiving the articular implant (¶ [0089]).
Regarding claim 14, Deransart further discloses the articular implant includes a spacer (see annotated fig. 4I, below) coupled to the threaded cup by a C-clip (183A, snap ring, figs. 4H and 4K), and a liner coupled to the spacer (see annotated fig. 4I, below).
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Regarding claim 15, Deransart further discloses the flange is provided on a first side of the cylindrical shaped body (see annotated fig. 5C, below) and the rounded base is provided on a second side of the cylindrical shaped body (see annotated fig. 5C, below), and the floor establishes an inner surface of the rounded base (see annotated fig. 5C, below).
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Regarding claim 17, Deransart fails to teach an engagement opening formed through the rounded base. However, Knox further discloses a at least one engagement opening form through the rounded base (see annotated fig. 3C, below). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the stemless implant of Deransart to include an engagement opening formed through the rounded base as taught by Knox since it is combining prior art elements according to known methods to yield predictable results, which courts have recognized supports a conclusion of obviousness (see MPEP 2143).
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Regarding claim 19, Deransart fails to teach the outer diameter of the flange is greater than the outer diameter of the body at a tip of the thread. However, Knox further discloses an outer diameter of the flange is greater than an outer diameter of the cylindrical shaped body at a tip of the thread (see annotated fig. 3A, below). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the stemless implant of Deransart to include the outer diameter of the flange is greater than the outer diameter of the body at a tip of the thread as taught by Knox since it is combining prior art elements according to known methods to yield predictable results, which courts have recognized supports a conclusion of obviousness (see MPEP 2143).
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Regarding claim 21, Deransart further discloses the articular implant includes a spacer coupled to the stemless implant (see annotated fig. 4I, below) and a liner coupled to the spacer (see annotated fig. 4I, below), and further wherein an entirety of the spacer is accommodated within the receiving cavity (¶ [0112], sloped surface 185A is the upper end of the spacer and engages the interior surface of the stemless anchor meaning the entirety of the spacer is within the anchor/recess).
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Regarding claim 23, Deransart further discloses the receiving cavity has a tapered profile extending from the flange to the floor of the rounded base (¶ [0008]) and is dimensioned to accommodate a substantial portion of the articular implant (¶ [0112]).
Regarding claim 24, Deransart further discloses the stemless implant is a cup (fig. 5A) having a hollow (fig. 5A), concave geometry defined by a circumferential wall surrounding the receiving cavity (212C, interior surface, fig. 5A).
Deransart fails to disclose the cup is threaded. However, Knox further discloses a threaded cup (224, helical structure, fig. 3A). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the stemless implant of Deransart to include a thread on the cup as taught by Knox since it is combining prior art elements according to known methods to yield predictable results, which courts have recognized supports a conclusion of obviousness (see MPEP 2143).
Regarding claim 25, Deransart in view of Knox fails to teach the ratio between the inner diameter of the circumferential wall and an outer diameter of the flange is between about 0.55-0.77. However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to teach the ratio between the inner diameter of the circumferential wall and an outer diameter of the flange is between about 0.55-0.77, 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 (see MPEP 2144.05).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Deransart in view of Knox as applied to claim 1 above, and further in view of Winslow (US 2010/0114326 A1).
Regarding claim 4, Deransart in view of Know fails to teach the stemless implant is comprised of a polyether ether ketone material. However, Winslow discloses a stemless implant for a ball and socket joint that includes a polyether ether ketone (PEEK) material (¶ [0010]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the stemless implant of Deransart and Knox to include comprising a polyether ether ketone material as taught by Winslow since it is a simple substitution of one known element for another to obtain predictable results, which courts have recognized supports a conclusion of obviousness (see MPEP 2143).
Claim(s) 10 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over in view of Knox as applied to claims 1 and 11 above, and further in view of Viscardi (US 2018/0104064 A1).
Regarding claim 10, Deransart in view of Knox fails to teach a plurality of suture eyelets. However, Viscardi discloses a stemless shoulder implant that includes a plurality of suture eyelets (211, holes, fig. 6B) that are each configured to receive a thread-like material (¶ [0079]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the flange of Deransart and Knox to include a plurality of suture eyelets as taught by Viscardi in order to be used for passing one or more sutures through to aid in fixation of an objection (¶ [0079], Viscardi) and since it is combining prior art elements according to known method to yield predicable results, which courts have recognized supports a conclusion of obviousness (see MPEP 2143).
Regarding claim 20, Deransart further discloses the cylindrical shaped body includes a plurality of pockets adapted to facilitate bony ingrowth (272B, porous surface, [0107]).
Deransart in view of Knox fails to teach a plurality of suture eyelets. However, Viscardi further discloses a plurality of suture eyelets (211, holes, fig. 6B) that are each configured to receive a thread-like material (¶ [0079]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the flange of Deransart and Knox to include a plurality of suture eyelets as taught by Viscardi in order to be used for passing one or more sutures through to aid in fixation of an objection (¶ [0079], Viscardi) and since it is combining prior art elements according to known method to yield predicable results, which courts have recognized supports a conclusion of obviousness (see MPEP 2143).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Deransart in view of Knox as applied to claim 15 above, and further in view of Bachmaier (US 2015/0134066 A1).
Regarding claim 18, Deransart in view of Knox fails to teach a trap door. However, Bachmaier further discloses the rounded based includes a trap door (the limitation trap door is being given the broad definition of hinged or removable due to the lack of hinge in the instant application drawings/specification, 410, short stem, fig. 6, covers the opening in the same manner and can be removed for insertion of the stem). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the stemless implant of Deransart and Knox to include a trap door as taught by Bachmaier since it is combining prior art elements according to known method to yield predicable results, which courts have recognized supports a conclusion of obviousness (see MPEP 2143).
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Deransart in view of Knox as applied to claim 21 above, and further in view of Pranzetti (US 2023/0414372 A1).
Regarding claim 22, Deransart in view of Knox fails to teach a cutout in the flange sized to receive a mating feature of the spacer. However, Pranzetti discloses a shoulder prosthesis that includes the flange includes a cutout that extends into a cylindrical shaped body of the stemless implant (124, cutouts, fig. 5), and further wherein the cutout is sized to receive a mating feature of the spacer (134, protrusions, fig. 5). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the flange of Deransart and Knox to include a cutout sized to receive a mating feature of the spacer as taught by Pranzetti in order to block relative rotations between components (¶ [0075], Pranzetti).
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Deransart in view of Knox as applied to claim 1 above, and further in view of Amstutz (US u,261,062 A).
Regarding claim 4, Deransart in view of Know fails to teach the flange is elliptical shaped. However, Amstutz discloses a shoulder prosthesis that includes the flange is elliptical shaped (col 3 lines 62-66). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the flange of Deransart and Knox to include an elliptical shape as taught by Amstutz since it is a simple substitution of one known element for another to obtain predictable results, which courts have recognized supports a conclusion of obviousness (see MPEP 2143).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TERESA M DUDDEN whose telephone number is (571)272-0435. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 pm 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 C 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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/T.M.D./Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774