DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Response to Amendment
This action is in response to Applicant’s amendment received 1/6/2026. The amendments made to the claims do not place the application in condition for allowance for the reasons set forth below. Claim 1-10 and 20 have been canceled and new claims 21-31 have been added. Claims 11-19 and 21-31 are pending.
Response to Arguments
Applicant's arguments filed 1/6/2026 have been fully considered but they are not persuasive. Applicant argues Knox fails to disclose or suggest that the receiving cavity is sized to provide an inlay design in which a majority of the articular implant is accommodated within the receiving cavity. However, Knox’s receiving cavity as illustrated in Fig. 1B receives implant 84 or 88 (see [0047]) and the portions of the implants received are interpreted as being a majority of the implant as claimed because it is the amount similar to that received in elected Figure 1 of the instant application (see also 112(b) rejection below for details). Applicant further argues Knox fails to disclose a threaded cup because element 104 is not described as a cup and lacks the defining geometry and terminology of a threaded cup. However, Knox discloses element 104 includes a cylindrical shaped body 260, a thread 224 provided on the cylindrical shaped body, a rounded base (see annotated figure below), and a receiving cavity (see Figs. 1B and 7) as claimed. Therefore, Knox discloses a “threaded cup” as claimed.
Election/Restrictions
New claim 27 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. The spacer and liner configuration recited in new claim 27 is encompassed by non-elected species 3. Election was made without traverse in the reply filed on 9/3/2025.
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 thread-like material wrapped around a suture block of the cage assembly recited in new claim 25 must be shown or the feature canceled from the claim. 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 Objections
Claim 31 is objected to because of the following informalities: typographical error in the last line. The last line should be amended as follows (see [0080]): “configured to engage and load against a cortical bone.” Appropriate correction is required.
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 11-19, 21-26, and 28-30 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 claims contain 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.
At the time the application was filed, the inventors failed to disclose the receiving cavity is sized to provide an inlay design “in which the majority of the articular implant is accommodated within the receiving cavity” as now recited in amended claim 1. Instead, the specification describes the receiving cavity 32 may provide an inlay design “In which a majority of the threaded cup 16 (with the exception of the flange 28) is disposed inside the humerus 14 post implantation” (see [0060]). Further, elected Fig. 1 illustrates the cavity is sized to receive only the projection of implant 18A. Therefore, the limitation is considered new matter.
At the time the application was filed, the inventors also failed to disclose “a ratio between an inner diameter of the cylindrical shaped body and an outer diameter of the flange is between about 0.55 and about 0.77” as recited in claim 30. The specification fails to describe any ratios. Therefore, the limitation is considered 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 11-19, 21-26, and 28-30 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.
Amended claim 11 recites “wherein the receiving cavity…is sized to provide an inlay design in which a majority of the articular implant is accommodated within the receiving cavity.” However, elected Fig. 1 illustrates the cavity is sized to receive only the projection of implant 18A which does not appear to be “a majority” of the implant. Therefore, the limitation is rendered indefinite as it is unclear as to what “a majority of the implant” entails. Claims 12-19, 21-26, and 28-30 are also rendered indefinite due to their dependency from indefinite claim 11.
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 11-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Knox et al. (US 2019/0175354).
Regarding claim 11, Knox discloses an arthroplasty implant system (see Fig. 3A) comprising a two-piece modular threaded cup (104) that includes a cylindrical shaped body (260), a thread (224) provided on the cylindrical shaped body, a flange (220) removably connectable to the cylindrical shaped body (see [0060] disclosing 220 can attach to 260, thereby is removably connectable thereto), a rounded base (see annotated figure below), and a receiving cavity (see Fig. 1B; the entire area that receives implant 84 or 88), wherein the thread (224) is configured to engage a bone and the flange (220) is sized to engage a cortical rim of the bone (see Figs. 3A, 7, [0055], [0060]), and an articular implant (84 or 88) received within the receiving cavity, wherein the receiving cavity extends inwardly from the flange to a floor of the rounded base (see annotated figure below) and is sized to provide an inlay design (a majority of the threaded cup is within bone after implantation; see Figs. 1B and 7) in which a majority of the articular implant is accommodated within the receiving cavity (see Fig. 1B in which the portion of the implant 84 or 88 received by the receiving cavity of the threaded cup is interpreted as a majority of the implant in the same way Applicant illustrates in Fig. 1).
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Regarding claim 12, Knox discloses the flange (220) is a separate component from the cylindrical shaped body (260) to establish the two-piece modular design of the threaded cup (see [0060] disclosing 220 can attach to 260, thereby is a separate component therefrom).
Regarding claim 13, Knox discloses the threaded cup (104) that establishes a convertible platform for receiving an articular implant (84).
Regarding claim 14, Knox discloses the flange (220) is provided on a first side (208) of the cylindrical shaped body (260) and the rounded base is provided on a second side (204) of the cylindrical shaped body (see annotated Fig. 7 above).
Regarding claim 15, Knox discloses the floor establishes an inner surface of the rounded base (see annotated Fig. 7 above).
Regarding claim 16, Knox discloses at least one engagement opening (272) formed through the rounded base.
Regarding claim 17, Knox discloses an outer diameter of the flange (220) is greater than an outer diameter of the cylindrical shaped body (260) at a tip of the thread (see Figs. 3A, 7).
Claims 11, 26, 28, and 31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Knox et al. (US 2020/0214845).
Regarding claims 11, 26, and 31, Knox discloses an arthroplasty implant system comprising a two-piece modular threaded cup that includes a cylindrical shaped body (of 104E), a thread provided on the cylindrical shaped body (see Fig. 32J), a flange (954B) removably connectable to the cylindrical shaped body (see [0145]), a rounded base (see Fig. 32J), and a receiving cavity (see Fig. 32J), the flange (954B) includes a tapered inner circumferential surface (tapers inward to form 960A), and the cylindrical shaped body includes a complementary tapered outer circumferential surface (tapers inward to form 964A) establishing an interference fit that permits removal and replacement of the flange (see [0151]), wherein the thread is configured to engage a bone and the flange is sized and configured to engage and load against a cortical rim of the bone (see Fig. 32I), and an articular implant (208 and 948) received within the receiving cavity, wherein the receiving cavity extends inwardly from the flange to a floor of the rounded base (see Fig. 32J) and is sized to provide an inlay design (a majority of the threaded cup is within bone after implantation; see Fig. 32A) in which a majority of the articular implant is accommodated within the receiving cavity (in which the portion of the implant received by the receiving cavity of the threaded cup is interpreted as a majority of the implant in the same way Applicant illustrates in Fig. 1).
Regarding claim 28, Knox discloses the cylindrical shaped body includes a plurality of pockets (pores in outer layer 268) positioned distal of a rim of the cylindrical shaped body (see Fig. 32J) and adapted to facilitate bony ingrowth (see [0094]).
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 18, 19, and 21-25 are rejected under 35 U.S.C. 103 as being unpatentable over Knox et al. (US 2019/0175354 or US 2020/0214845) as applied to claim 11 above, and further in view of Anthony et al. (US 2013/0261754).
Regarding claims 18 and 19, Knox discloses an inserter system that includes a drive shaft (662) and a shaft assembly (666) connected to the drive shaft and configured to engage the cylindrical shaped body (see Fig. 14 and [0092]). Knox fails to disclose a cage assembly configured to engage the flange, wherein the cage assembly includes a mounting leg having a tapered tooth configured to engage a tapered slot of the flange.
Anthony also discloses an inserter system (see Fig. 37) for delivering an implant having a cylindrical body and flange (for example, see Figs. 43-44). Anthony teaches a cage assembly configured to engage the flange (see Fig. 37), wherein the cage assembly includes a mounting leg (560) having a tapered tooth (562) configured to engage a tapered slot (30) of the flange. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided Knox’s flange with a tapered slot and Knox’s inserter system with a cage assembly configured to engage the flange, wherein the cage assembly includes a mounting leg having a tapered tooth configured to engage a tapered slot of the flange, as taught by Anthony. Doing so would provide a means to prevent the implant from rotating relative to the threaded inner shaft upon rotation thereof, thereby facilitating engagement and disengagement of the inner shaft’s threaded distal tip to and from the implant (see [0158]).
Regarding claim 21, Knox as modified is silent as to the structure of the shaft assembly. Anthony further teaches a shaft assembly including an outer shaft (542) and an inner shaft (548) accommodated within a bore (544) of the outer shaft (see [0154]), the inner shaft (548) includes a threaded distal tip (tip having threads 556) for engaging a threaded engagement opening formed through the base of the implant (see [0156]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Knox’s shaft assembly to include an outer shaft and an inner shaft accommodated within a bore of the outer shaft, the inner shaft including a threaded distal tip for engaging a threaded engagement opening formed through the rounded base of the two-piece modular threaded cup, as taught by Anthony, in order to provide a sufficient means for engaging and subsequently deploying the implant (see [0158]). Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the outer shaft and cage assembly as separate components having known connection means such as cooperating threads for securing the shaft assembly to the cage assembly, since it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art. Nerwin v. Erlichman, 168 USPQ 177, 179.
Regarding claim 22, Knox as modified discloses the inner shaft (548) is secured to the outer shaft (542) by a capture pin (550 is a cylindrical component that secures 548 to 542 as seen in Fig. 37).
Regarding claim 23, Knox as modified discloses the cage assembly includes a proximal portion (560) that accommodates a portion of the shaft assembly and a distal portion (526) that interfaces with the flange.
Regarding claim 24, Knox as modified discloses the drive shaft is rotatable to cause the shaft assembly to screw the cylindrical shaped body through the flange as the flange is being held against the cortical rim by the distal portion of the cage assembly (668 is rotatable which would rotate the assembly in turn if rotated screwing the cylindrical shaped body as claimed if the separate flange component were to be held against the cortical rim by the cage assembly).
Regarding claim 25, Knox as modified fails to disclose the flange includes a plurality of suture eyelets that are each configured to receive a thread-like material, and the thread-like material is routed through a slot formed in the cage assembly and is wrapped around a suture wrap block of the cage assembly. Anthony further teaches the flange includes a plurality of suture eyelets (26) that are each configured to receive a thread-like material (see [0066]; and the thread-like material is capable of being routed through a slot formed in the cage assembly and wrapped around a suture wrap block of the cage assembly). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Knox’s flange to include a plurality of suture eyelets that are each configured to receive a thread-like material routed through a slot formed in the cage assembly and wrapped around a suture wrap block of the cage assembly, as taught by Anthony, in order to provide a means for suturing the implant to bone wafers or soft tissue (see [0066]).
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Knox et al. (2019/0175354 or US 2020/0214845) in view of Habermeyer et al. (US 2007/0282450).
Knox discloses the claimed invention except for a plurality of anti-rotation tabs protruding from a distal-facing surface of the flange and impactable into the cortical rim to resist rotation. Habermeyer also discloses an arthroplasty implant system (shoulder joint prosthesis 1) comprising a flange (11). Habermeyer teaches a plurality of anti-rotation tabs (13) protruding from a distal-facing surface of the flange (see Fig. 4) and impactable into the cortical rim to resist rotation (see [0019]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the flange of Knox to include a plurality of anti-rotation tabs protruding from a distal-facing surface of the flange and impactable into the cortical rim to resist rotation as taught Habermeyer in order to enhance securement of the implant in bone after implantation ([0019]).
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Knox et al. (US 2019/0175354 or US 2020/0214845)
Knox discloses the claimed invention except for the ratio between an inner diameter of the cylindrical shaped body and an outer diameter of the flange. However, there is no evidence of record that establishes that changing ratio between an inner diameter of the cylindrical shaped body and an outer diameter of the flange would result in a difference in function of Knox’s device. Further, a person of ordinary skill in the art, being faced with modifying the ratio between an inner diameter of the cylindrical shaped body and an outer diameter of the flange of Knox, would have a reasonable success in making such a modification and it appears the device would function as intended given the claimed ratio. Lastly applicant has not disclosed that the claimed ratio solves any stated problem or is used for a particular purpose, failing to disclose any particular ratio and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the ratio between an inner diameter of the cylindrical shaped body and an outer diameter of the flange to between about 0.55 and about 0.77 as an obvious matter of design choice within the level of skill in the art.
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 MELANIE TYSON whose telephone number is (571)272-9062. The examiner can normally be reached M-F 8:00 AM - 4:00 PM (ET).
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/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774