DETAILED ACTION
The following is a final office action is response to communications received on 05/11/2026. Claims 1-20 are currently pending and addressed below.
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 filed 05/11/2026 have been fully considered but they are not persuasive.
On pages 8-9, applicant argues that the annotated version of Iannotti et al. (US 2010/0161066) FIG. 8 set forth in the Action fails to demonstrate how the first and second convex surfaces intersect and instead identifies where the augment 140 extends from the scapula-facing side 139 of base 136. Applicant argues that the two convex surfaces identified by the exmanier do not intersect at all.
The examiner respectfully disagrees. Claim 1 recites the augment (140) portion having a bone-contacting surface defining a first convexity (shown), the bone-contacting surface of the main body having a second convexity (139), and wherein the bone-contacting surface of augment portion and the bone-contacting surface of the main body portion intersect at an interface. It is the examiner’s position that the entirety of the augment (140), which includes first convexity (shown) as well as the wall components (at 141) extending to surface 139, are considered the bone-contacting surface of the augment. Therefore, the annotated figure of the previous action illustrates where the bone-contacting surface of augment portion and the bone-contacting surface of the main body portion intersect at an interface (shown).
On page 9, applicant argues that one of ordinary skill in the art would have combined Iannotti and Winslow (US 8,425,614). Applicant argues that Winslow expressly teaches away from removing significant portions of the scapula.
The examiner respectfully disagrees. Winslow teaches a prosthetic glenoid component that is used to replace the glenoid surface following degenerative changes to the shoulder joint (Col 1: lines 23-26). Iannotti teaches a prosthetic glenoid component that is used following erosion (i.e., a degenerative change) of the glenoid [0002]. Winslow doesn't warn against the use of an augment. He merely states that an excessive number of pegs used to anchor the device can increase the amount of bone removed (Winslow Col 1: lines 49-55). It is well known in the art that maintaining healthy, non-degenerative, bone stock is a major focus in orthopedic surgeries. As both Winslow and Iannotti address this issue, their combination would be obvious.
In In re Gurley, 27 F.3d 551,553 (Fed. Cir. 1994), the Court stated the general rule to determine whether a reference "teaches away": "[a] reference may be said to teach away when a person of ordinary skill, upon reading the reference, would be discouraged from following the path set out in the reference, or would be led in a direction divergent from the path that was taken by the applicant". The Court further explained its holding in that the degree of teaching away will of course depend on the particular facts; in general, a reference will teach away if it suggests that the line of development flowing from the reference's disclosure is unlikely to be productive of the result sought by the applicant. A reference does not teach away, however, if it merely expresses a general preference for an alternative invention but does not "criticize, discredit, or otherwise discourage" investigation into the invention claimed. In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004). Moreover, a reference that "teaches away" does not per se preclude a prima facie case of obviousness, but rather the "teaching away"of the reference is only a factor to be considered in determining nonobviousness. In re Gurley, at 553.
An updated rejection is made infra addressing all of the claim limitations as necessitated by amendment.
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 5 & 12-20 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.
Claims 5 & 12 state wherein the bone-contacting surfaces meet at the interface and define an angle transverse from the an anterior-posterior axis of the glenoid implant system. This new limitation is indefinite as it is unclear how such an angle could be measured. An angle is measured between two line segments or planes, and it is unclear how this measurement could be quantified between two convex bone-contacting surfaces. Appropriate correction is required.
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.
Claim(s) 1-3, 5-8 & 10-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Winslow et al. (US 8,425,614) in view of Iannotti et al. (US 2010/0161066).
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Regarding Claim 1, Winslow discloses the invention substantially as claimed. Winslow teaches a glenoid implant system (Fig 2) comprising: a main body (20) defining an articulating surface (24) configured to articulate with a humeral head (Col 3: line 65-Col 4: line 1), and an opposite bone-contacting surface (26) adapted to contact the glenoid of a patient and defining a periphery (shown) of the main body; a base (34/40) formed in the bone-contacting surface of the main body (Fig 5B); and an anchor (48) having a main section (shown) and an anti-rotation feature (shown as the planar cylindrical surface that contacts bushing 40) disposed on a base of the anchor, the anti-rotation feature adapted to contact the base (34/40) formed in the bone-contacting surface of the main body when the anchor is coupled to the base (via threads in Fig 2); and wherein the bone-contacting surface of the main body has a second convexity (shown).
However, Winslow does not disclose an augment portion positioned on the main body, formed separately from the main body, the augment portion having a bone-contacting surface defining a first convexity, the first convexity being adapted to contact a neoglenoid portion of the glenoid, and the second convexity being configured to contact a paleoglenoid portion of the glenoid, wherein the bone-contacting surface of augment portion and the bone-contacting surface of the main body portion intersect at an interface, the interface extending from a first location at the periphery of the main body to a second location remote from the first location.
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Iannotti teaches a glenoid component (130) in the same field of endeavor. Said glenoid component comprising an augment (140) with a first convexity (shown), different than a bone-contacting second convexity (139), and formed separately [0029] from the main body on the bone-contacting surface to fill any bone deficiencies on the glenoid [0001]. Further, Iannotti teaches wherein the bone-contacting surface of augment portion and the bone-contacting surface of the main body portion intersect at an interface (shown), the interface extending from a first location (shown) at the periphery (142) of the main body to a second location (shown) remote from the first location.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to add the augment, as taught by Iannotti, to the bone contacting side of the implant of Winslow in order to create a device to replace the glenoid surface as well as any underlying bone deficiencies. The proposed device would comprise an augment portion positioned on the main body, formed separately from the main body, the augment portion having a bone-contacting surface defining a first convexity, the first convexity being different than the second convexity, wherein the bone-contacting surface of augment portion and the bone-contacting surface of the main body portion intersect at an interface, the interface extending from a first location at the periphery of the main body to a second location remote from the first location. Further, as the augment is used to fill/occupy the degenerated section of the glenoid, the first convexity would be adapted to contact a neoglenoid (i.e., new) portion of the glenoid, while the second convexity would be configured to contact a paleoglenoid (old) portion of the glenoid.
Regarding Claim 2, the combination teaches wherein the main body is formed from a polymer material (Col 6: lines 44-46).
Regarding Claim 3, the combination teaches the claimed invention except for wherein the augment portion is formed from a metal material. Further, Winslow teaches that the body can be coated with metallic powder coating to promote ingrowth on bone-facing surfaces (Col 7: lines 25-31). It would have been obvious to one having ordinary skill in the art at the time the invention was made to construct the augment (or a portion thereof) from a metal material to promote bone-ingrowth along the augment surface. It has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding Claim 5, as best understood (see 112 rejection supra), the combination teaches wherein the bone-contacting surface of the main body (139) and the bone-contacting surface of the augment (shown) portion meet at the interface and define an angle (shown) transverse from the an anterior-posterior axis of the glenoid implant system.
Regarding Claims 7 & 14, the combination teaches wherein the anchor (48) further includes a threaded post extending from the main section, the threaded post (51) being configured to be received within a hole (shown) formed in the base formed in the bone-contacting surface of the main body (Fig 2).
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Regarding Claim 8, the combination teaches wherein the anchor (48) includes a plurality of ribs (shown in Fig 7B) extending in a longitudinal direction of the main section, the plurality of ribs being spaced apart from one another in a circumferential direction of the main section.
Regarding Claim 10, the combination teaches wherein the augment portion includes an augment anchor (shown) fully capable of engaging a neoglenoid portion of a humerus.
Regarding Claim 11, the combination teaches wherein the augment anchor (shown) is integral with the augment portion (Fig 8).
Regarding Claims 12 & 13, the combination teaches the device as set forth in the rejection of claims 1, 5 & 7 supra. Further, Winslow teaches wherein the anchor (48) includes at least one ridge (shown as “ribs”) extending along a side wall of the main section (shown) (Fig 7B).
Regarding Claim 15, the combination teaches wherein the anchor includes a center anchor (shown) and at least one peripheral anchor (shown), and the base formed in the bone-contacting surface of the main body includes a center base (at center anchor) and at least one peripheral base (at peripheral anchor), the center base being positioned in a central area of the bone-contacting surface of the main body (Fig 2).
Allowable Subject Matter
Claims 4, 6 & 9 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.
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 BRIAN AINSLEY DUKERT whose telephone number is (571)270-3258. The examiner can normally be reached Mon-Fri 6am-4pm.
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, Melanie Tyson can be reached at (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN A DUKERT/Primary Examiner, Art Unit 3774
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