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 .
Response to Amendment
This office action is responsive to the amendment filed on 06/22/2026. As directed by the amendment: claims 1, 4, have been amended, claims 6, 21-86 have been canceled and claims 87, 88 are new. Thus, claims 1-5, 7-20 and 87-88 are presently pending in the application.
Response to Arguments
Applicant's arguments filed 06/22/2026 have been fully considered but they are not persuasive. Applicant argues the prior art Van Dyke et al.
Allowable Subject Matter
Claims 10, 12 is 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. Regarding Claim 10, the prior art fails to teach nor render obvious wherein the second aperture extends through at least one of the plurality of grooves. Regarding Claim 12, the prior art fails to teach nor render obvious wherein the longitudinal centerline of each of the first and second apertures is angled 30° relative to the longitudinal plane of the stem
Claims 13-18 are allowed. The following is a statement of reasons for the indication of allowable subject matter: the closest prior art Van Dyke et al. discloses a system, comprising: the stem of Claim 1 (see rejection below), wherein each aperture of the plurality of apertures 138, 142 comprises a first opening, a second opening, and a length measured along a longitudinal centerline therebetween (as seen in Figures 1A-1E). However, Van Dyke et al. does not expressly disclose nor render obvious at least one plug configured to be received by one or more apertures of the plurality of apertures of the stem. Claims 14-18 depends on claim 13.
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 .
Allowable Subject Matter
Claims 1-5, 7-20 and 88 are allowed.
The following is an examiner’s statement of reasons for allowance: the closest prior art Van Dyke et al. U.S. Publication 2016/0310176 A1 discloses Claims 1 and 19, a stem for a shoulder prosthesis 100 as seen in Figures 1A-1B (paragraphs [0046-0047] and [0050]) comprising: a medial side (to the left side of the longitudinal axis as seen in Figure 1B and paragraphs [0046] and [0050]); a lateral side opposite the medial side (side positioned on the right side of the longitudinal axis 108 as seen in Figure 1B and paragraph [0046], [0050] and [0056]); and a plurality of apertures 116, 118, 126, 128, 138, 142, each aperture of the plurality of apertures configured to receive a screw 120, 122, 132, 134, 136, 144, 146 or one or more plugs (paragraphs [0048], [0054-0055]), the plurality of apertures comprising a first aperture and a second aperture, wherein the first aperture 138 is positioned proximal to the second aperture 142 (paragraphs [0054-0055]), wherein each of the first and second apertures 138, 142 comprises a first opening on the medial side, a second opening on the lateral side (paragraph [0056] and [0059-0060]), and a length measured along a longitudinal centerline therebetween, the longitudinal centerline of at least one of the first and second apertures being angled relative to a longitudinal plane extending in a medial-lateral direction of the stem (as seen in Figures 1A-1E and paragraphs [0056], [0059-0060]). Van Dyke et al. further discloses wherein the distal shaft portion 106 comprises the plurality of apertures 116, 118 (which was described as extending at any angle, in any direction through the distal portion 106, therefore, the longitudinal centerline of at least one of the first and second apertures being angled relative to a longitudinal plane extending in a medial- lateral direction of the stem as seen in the apertures of 138, 142). However, Van Dyke et al. does not expressly teach nor render obvious wherein an angle between the longitudinal centerline of at least one of the first and second apertures and the longitudinal plane is between 15 degrees to about 75 degrees. Regarding Claim 10, the prior art fails to teach nor render obvious wherein the second aperture extends through at least one of the plurality of grooves. Regarding Claim 12 the prior art fails to teach nor render obvious wherein the longitudinal centerline of each of the first and second apertures is angled 30° relative to the longitudinal plane of the stem.
Regarding Claim 13, Van Dyke et al. discloses a system, comprising: the stem of Claim 1 (see rejection above), wherein each aperture of the plurality of apertures 138, 142 comprises a first opening, a second opening, and a length measured along a longitudinal centerline therebetween (as seen in Figures 1A-1E). However, Van Dyke et al. does not expressly disclose nor render obvious at least one plug configured to be received by one or more apertures of the plurality of apertures of the stem.
Regarding Claim 88, Van Dyke et al. discloses a stem for a shoulder prosthesis 100 as seen in Figures 1A-1B (paragraphs [0046-0047] and [0050]) comprising: a medial side (to the left side of the longitudinal axis as seen in Figure 1B and paragraphs [0046] and [0050]); a lateral side opposite the medial side (side positioned on the right side of the longitudinal axis 108 as seen in Figure 1B and paragraph [0046], [0050] and [0056]); and a plurality of apertures 116, 118, 126, 128, 138, 142, each aperture of the plurality of apertures configured to receive a screw 120, 122, 132, 134, 136, 144, 146 (paragraphs [0048], [0054-0055]), the plurality of apertures comprising a first aperture and a second aperture, wherein the first aperture 138 is positioned proximal to the second aperture 142 (paragraphs [0054-0055]), wherein each of the first and second apertures 138, 142 comprises a first opening on the medial side, a second opening on the lateral side (paragraph [0056] and [0059-0060]), and a length measured along a longitudinal centerline therebetween, the longitudinal centerline of at least one of the first and second apertures being angled relative to a longitudinal plane extending in a medial-lateral direction of the stem (as seen in Figures 1A-1E and paragraphs [0056], [0059-0060]). Regarding Claim 12 the prior art fails to teach nor render obvious wherein the longitudinal centerline of each of the first and second apertures is angled 30° relative to the longitudinal plane of the stem.
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.
Claim(s) 87 is/are rejected under 35 U.S.C. 103 as being unpatentable over Van Dyke et al. U.S. Publication 2016/0310176 A1 in view of Deransart et al. WO 2016/094739 A1.
Regarding Claim 87, Van Dyke et al. discloses a stem for a shoulder prosthesis 100 as seen in Figures 1A-1B (paragraphs [0046-0047] and [0050]) comprising: a medial side (to the left side of the longitudinal axis as seen in Figure 1B and paragraphs [0046] and [0050]); a lateral side opposite the medial side (side positioned on the right side of the longitudinal axis 108 as seen in Figure 1B and paragraph [0046], [0050] and [0056]); and a proximal portion having a stem face; and a plurality of apertures 116, 118, 126, 128, 138, 142, each aperture of the plurality of apertures configured to receive a screw 120, 122, 132, 134, 136, 144, 146 (paragraphs [0048], [0054-0055]), the plurality of apertures comprising a first aperture and a second aperture, wherein the first aperture 138 is positioned proximal to the second aperture 142 (paragraphs [0054-0055]), wherein each of the first and second apertures 138, 142 comprises a first opening on the medial side, a second opening on the lateral side (paragraph [0056] and [0059-0060]), and a length measured along a longitudinal centerline therebetween, the longitudinal centerline of at least one of the first and second apertures being angled relative to a longitudinal plane extending in a medial-lateral direction of the stem (as seen in Figures 1A-1E and paragraphs [0056], [0059-0060]). In addition, Van Dyke et al. discloses a distal shaft portion adapted to be anchored in a medullary canal of a humerus 110 (as seen in Figure 1 and paragraph [0047]). However, Van Dyke et al. does not expressly disclose a proximal portion having a stem face, and a metaphyseal portion extending between and connecting the distal shaft portion and the proximal portion. Deransart et al. teaches a shoulder prosthesis in the same field of endeavor comprising a stem 30 having a distal shaft portion 32 and a proximal portion 34 (paragraph [0079] and as seen in Figures 1A-3) and a metaphyseal portion 90 (paragraph [0092]) for the purpose of providing accurate support to restore the tuberosities positions and promote tuberosity healing and inhibit tuberosity resorption (paragraph [0092]). 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 Van Dyke’s shoulder prosthesis to further include a stem having a proximal portion, a metaphyseal portion extending between and connecting a distal shaft portion and the proximal portion as taught by Deransart et al. for the purpose of providing accurate support to restore the tuberosities positions and promote tuberosity healing and inhibit tuberosity resorption.
Van Dyke et al. does not expressly disclose wherein the distal shaft portion comprises a plurality of grooves extending in a longitudinal direction, wherein the plurality of grooves are circumferentially spaced apart. Deransart et al. teaches a shoulder prosthesis in the same field of endeavor comprising a stem 30 having a distal shaft portion 32 comprising a plurality of grooves that extend in a longitudinal direction and are circumferentially spaced apart (1A-3 and 19) for the purpose of having a distal shaft portion that can fuse with the medullary canal of a humerus and stabilize the device (paragraph [0017]). 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 Van Dyke’s shoulder prosthesis to further include a distal shaft having a plurality of grooves that extend in a longitudinal direction and are circumferentially spaced apart as taught by Deransart et al. for the purpose of having a distal shaft portion that can fuse with the medullary canal of a humerus and stabilize the device.
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 SEEMA MATHEW whose telephone number is (571) 270-1452. The examiner can normally be reached on Monday-Friday 9 am – 5 pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, SPE, Melanie Tyson 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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/SEEMA MATHEW/
Primary Examiner, Art Unit 3774
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