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 .
Election/Restrictions
Applicant’s election without traverse of Invention II, claims 13-17, in the reply filed on 3/24/2026 is acknowledged.
Claims 1-12 and 18-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 3/24/2026.
Claim Objections
Claim 17 is objected to because of the following informalities: In claim 17, line 3, “release” is believed to be in error for --releases--. Appropriate correction is required.
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 13-17 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 13, lines 4-5 recite “an inner surface extending between a peripheral edge of said outer hemispherical surface” but this is indefinite because it is not clear where the inner surface extends since “a peripheral edge” is claimed and no other location is specified. In other words, when something extends “between” it typically extends between two locations/structures. In this case, the inner surface extends between a peripheral edge and what?
In claim 13, line 5 after “surface” a colon is used but this implies the structure which follows the inner surface is part of the inner surface. It appears that the colon may be a typo for a semicolon.
Claim 13 is further unclear because line 17 requires that the outwardly-extending member is “releasably coupled in said eccentric cavity”, lines 24-25 refer to “said outwardly-extending member”, and lines 26-27 require that “the outwardly-extending member” is “releasably and adjustably coupled in said eccentric cavity”. First, it is unclear if the outwardly-extending member of lines 24-25 and line 26 are the same as the outwardly-extending member of line 17. It appears the outwardly-extending member of lines 24-25 and line 26 may each be directed to the outwardly-extending member of the trial offset adapter. Please amend the claims to distinguish between the outwardly-extending member recited in lines 24-25 and 26 from the outwardly-extending member recited in lines 17. Second, it is unclear how both the outwardly-extending member of the pin guide and the outwardly-extending member of the trial adapter can be “coupled in said eccentric cavity”. How can both be positively coupled in the same cavity? Par. 68 of the specification discloses “the trial humeral head 400 and the pin guide 500 are used for installing the humeral anchor 300, and the trial humeral head 400 and the trial offset adapter 600 are used for trialing the trial humeral head 400 and selecting the appropriate offset adapter 200”. Therefore, it appears the pin guide and trial offset adapter are interchangeably coupled in the eccentric cavity and are never coupled in the cavity at the same time. Applicant may consider amending the claim to clarify that the outwardly-extending members are configured to be coupled in the eccentric cavity.
Claim 14, line 2 recites “said outwardly-extending member” in line 2. It is unclear which outwardly-extending member this refers to since there is an outwardly-extending member of the pin guide and an outwardly-extending member of the trial offset adapter.
Claim 14 recites the limitation "the humeral head" in line 3. There is insufficient antecedent basis for this limitation in the claim. It is unclear if this is referring to an anatomical humeral head, the trial humeral head, or a humeral head component. Note that if this was meant to be the trial humeral head, it appears “a central axis” in line 3 of claim 14 should be --the central axis--.
Allowable Subject Matter
Claims 13-17 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter:
The following references are considered the closest prior art:
Hartdegen et al. US 2001/0053935 (cited in the IDS)
Iannotti et al. US 2013/0150975
Humphrey US 2015/0250601
Paterson et al. US 2019/0216615
Hartdegen et al. discloses a trial humeral head system comprising a trial humeral head 34 comprising an outer hemispherical surface (figs. 7-8), an inner surface extending between a peripheral edge of the outer hemispherical surface (as best understood this refers to the bottom surface as shown in fig.7), an aperture 66 extending from the outer hemispherical surface to the inner surface (fig.7), the outer hemispherical surface defining a central axis extending from the outer hemispherical surface to the inner surface (the central axis is shown in fig.7 at the center of the head), and the inner surface comprising a cavity extending around the aperture (fig.7), and a trial offset adapter 36 comprising: a tapered cylindrical portion 42, an outwardly-extending member (considered the wider portion in figs. 3-4 and 8) secured to the tapered cylindrical portion, a passageway 68 extending from the first tapered cylindrical portion to the outwardly-extending member (fig.4), and the outwardly-extending member configured to be releasably and adjustably coupled in the cavity of the trial humeral head (figs. 7-8 show that the at least a portion of the outwardly-extending member can be releasably and adjustably (can be rotated) in the cavity of the trial head). While Hartdegen et al. discloses some of the features of the trial humeral head as claimed, Hartdegen et al. does not disclose that the central axis of the outer hemispherical surface extends through the aperture. Instead, the aperture is offset from the center of the head as shown in fig.7. Hartdegen et al. further does not disclose an eccentric cavity around the aperture and does not disclose a pin guide configured to be coupled in the eccentric cavity of the trial humeral head.
Iannotti et al. discloses a trial head system comprising: a trial head 7175 comprising an outer hemispherical surface (see the outer surface of 7175 in fig.96), an inner surface extending between a peripheral edge of the outer hemispherical surface (as best understood this is interpreted to be the bottom surface shown in fig.96), an aperture extending from said outer hemispherical surface to said inner surface (see the central aperture in fig.96), the outer hemispherical surface defining a central axis extending from the outer hemispherical surface to the inner surface and through the aperture (fig.96), and the inner surface comprising an eccentric cavity extending around the aperture (fig.96 shows an eccentric cavity for receiving 7170), a trial offset adapter 7170 comprising a tapered cylindrical portion (lower portion of 7170), an outwardly-extending member (upper portion of 7170) secured to the tapered cylindrical portion, a passageway extending from the first tapered cylindrical portion to the outwardly-extending member (fig.96 shows a through passageway receiving screw 7172), and said outwardly-extending member configured to be releasably and adjustably coupled in the eccentric cavity of the trial head (fig.96). While Iannotti et al. discloses a trial head and trial offset adapter as claimed, the trial head of Iannotti et al. is for a glenoid and is therefore not considered a trial humeral head. Further, Iannotti et al. does not disclose a pin guide as claimed.
Humphrey and Paterson et al. each disclose pin guides comprising an elongated member, a passageway through the elongated member from a first end to a second end, and an outwardly extending member secured to the first end of the elongated member (see Humphrey figs.53-54 and Paterson et al. fig.2). However, the pin guides of Humphrey and Paterson et al. are designed to be used alone and are not configured to be coupled in an eccentric cavity of a trial head with the elongated member extending through an aperture of the trial head and with the passageway concentric with the central axis of the trial head. Therefore, there would be no reason to combine the trial head and trial offset adapter of either of Hartdegen et al. or Iannotti et al. with the pin guide of either of Humphrey and Paterson et al. since the pin guides taught by Humphrey and Paterson et al. are not designed to be coupled in an eccentric cavity of a trial head with the elongated member extending through an aperture of the trial head, and instead are intended to be used without a trial head or adapter.
In conclusion, the prior art does not disclose, teach, or suggest, the combination of a trial humeral head as claimed, a pin guide as claimed, and a trial offset adapter as claimed.
If applicant would like for any withdrawn claims to be rejoined, applicant must incorporate all of the allowable subject matter of claim 13 into the withdrawn claims. Please carefully check for informalities and indefiniteness upon amending the withdrawn claims to include the allowable subject matter to prevent any delay in allowance.
Conclusion
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/MEGAN Y WOLF/Primary Examiner, Art Unit 3774
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