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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/09/2025 has been entered.
Priority
This application claims priority from provisional application 62/906,237, filed 09/26/2019.
Status of Claims
Claims 1, 2, 6-8, 10, 12, 13, 16-19, 21, 23, 25-27, and 29-32 are pending.
Claims 25-27 have been withdrawn from consideration.
Claims 3-5, 9, 11, 14, 15, 20, 22, 24, and 28 have been cancelled.
Election/Restrictions
Applicant elected Invention I (Apparatus) and Species 4 (Figures 4D-E) on 01/03/2025. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)).
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 asymmetric screw hole spacing (claims 1 and 12 see 112 rejection below for more details), must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Additionally, Figure 4E is objected to as being inconsistent with its description within the specification. The applicant has now defined Figure 4E with a new reference number and argues that it is a different embodiment than that shown in Figure 4D. However, [0040] still describes this embodiment as being asymmetric, but a quick require of even the amended figure clearly shows a symmetric shape. Clarification is required as to how this embodiment qualifies as asymmetric.
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 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 1, 2, 6-8, 10, 12, 13, 16-19, 21, 23, and 29-32 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.
The claims include numerous recitations with respect to screw holes being asymmetrically spaced around the outer surface of the central body, but this does not appear to be consistent with the elected embodiment shown in Figures 4D-E. This was pointed out with regards to both the projections and fixation sites in the previous office action but the applicant failed to clarify how the amendments overcome this issue. Previously, the applicant pointed to [0061] of the publication to support the prosthesis 400 as being asymmetrical. However, this recitation is not consistent with the current claim language. The claims specifically require the screw holes to be asymmetrical around the outer surface of the central body of the prosthesis. However, it is unclear how when there are only two components on an irregular shaped body, they can be considered asymmetrical around the body. The body doesn’t have a single orientation and the claims fail to define the implant being in a specified position. If the body is asymmetrical as depicted in Figure 4D how can one identify if the projections or fixation sites are symmetrical or asymmetrical. The applicant added an arbitrary lateral axis 440 with the lower fixation site being offset, but there is no specificity with respect to the location or angle of the lateral axis within the claims. As seen below depending on how the line is drawn, the two screw holes can be aligned symmetrically about the body.
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The two figures above are exactly the same but have been rotated relative to the applicant’s reference line to show the screw holes in opposing configurations. Whenever there are only two objects but they are opposite each on a surface they can be usually be considered to be symmetrically spaced about that object because there is nothing to signify the odd, offset, or irregular asymmetrical spacing. The orientation with respect to a single line cannot justify a conclusion of asymmetrical or symmetrical spacing because as seen above it can be arbitrarily rotated. Therefore a person of ordinary skill in the art would not be able to determine if the screw holes are actually symmetrical or asymmetrically spaced.
Information Disclosure Statement
The information disclosure statement filed on 10/09/2025 has been considered by the examiner.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1, 2, 6-8, 10, 12, 13, 16-19, 21, 23, and 29-32 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Angibaud et al (Angibaud) US 2012/0209392 A1.
1. Angibaud discloses a reverse prosthetic component (abstract) comprising:
a central body 110 having a longitudinal axis normal to a reference plane that extends through the central body (numerous options for both the axis and plane are identifiable within Figures 6A-C, furthermore since the longitudinal axis is not limited with respect to the body and the reference plane is only required to be normal to the longitudinal axis, both the longitudinal axis and reference plane can be identified in a variety of angles with respect to the body while still being normal to each other), and a lateral axis in the reference plane (there are an infinite number of axis that extend through the plane that can be called a lateral axis), the central body having an asymmetric perimeter (the body of Angibaud has a variety of perimeters depending on the orientation of the viewer, as shown in Figure 6C there is an asymmetric perimeter because the left side has a continuous curve and the right side has a plurality of additional projections and recesses)
a plurality of projections 112/114 extending from an outer surface of the central body (Figures 8A-C), wherein the plurality of projections provide fixation for the reverse prosthetic component in a bone of a subject (Figures 3AB Abstract)
a plurality of screw holes 122 extending through the central body (Figures 6A-D), wherein the plurality of screw holes are configured to receive one of the plurality of projections (Figures 8A-C) to provide fixation for the reverse prosthetic component in a bone of a subject, the plurality of screw holes being asymmetrically spaced around the outer surface of the central body in the reference plane (identifying the lower central hole and the upper right hold shown in Figure 6B provides for screw holes being spaced asymmetrically about the reference plane)
wherein the reverse prosthetic component is not mirrored from a left side to a right side across a reflection plane in the longitudinal axis and the lateral axis. (the location of the reflection plane is open to broad limitation because the claims do not provide specific requirement for the location of the longitudinal axis or lateral axis or the persons perspective when viewing the component, for example if the longitudinal axis of Angibaud is identified as the central longitudinal axis of member 112 and the lateral axis is identified to the right of it but between the upper and lower right screw holes, the body is not going to be a mirror because the upper portion of the body shown in Figures 6A-6D would be smaller than the lower body portion divided by a reflection plane extending through the two axis. Furthermore the plane is only required to be running through the axis. The claims do not require it to be parallel to or at a specific angle with respect to the axis. This allows the plane to be shifted/rotated/tilted in a variety of configurations achieving non-mirrored portions.)
2. Angibaud discloses a first projection 114 of the plurality of projections has a first projection length (Figure 8C), the first projection length defined by a first distance from the central body to an outermost end of the first projection (Figure 8C), a second projection 112 of the plurality of projections has a second projection length (Figure 8C), the second projection length defined by a second distance from the central body to an outermost end of the second projection (Figure 8C), wherein the second projection length is less than the first projection length (Figure 8C).
6. Angibaud discloses at least one of the plurality of projections is a peg 112 or screw 114, or has an oblique angle with respect to the reference plane (Figures 8A-C show oblique angled screws).
7. Angibaud discloses the plurality of projections each have an oblique angle with respect to the reference plane and the oblique angles are asymmetric in a reflection plane along the longitudinal axis (due to the broadly claimed reference plane, which can be tilted or rotated in a variety of orientations, all screws and the central peg can be considered positioned at a plurality of different oblique angles, furthermore Figure 8C shows the uppermost screw and second lowest screw as being at different oblique angles).
8. Angibaud discloses the central body and the plurality of projections are dimensioned for implantation into a glenoid of a subject (abstract).
10. Angibaud discloses the prosthesis comprises at least one of: four projections, or five projections, or six projections, or is a modular prosthesis (the applicant’s elected embodiment only discloses 2 projections (Figures 4D-E) Angibaud discloses at least 4 projections (Figure 8A-C), but both the applicants and Angibaud inventions are both considered modular because of the removable screws).
12. Angibaud discloses a prosthesis (it is noted that any bone plate can qualify as prior art because there are no recitations of implant type or intended use) comprising:
a central body 110 having a longitudinal axis normal to a reference plane that extends through the central body (see explanation with respect to claim 1 above); and a lateral axis in the reference plane (see explanation with respect to claim 1 above) the central body having an asymmetric perimeter (the body of Angibaud has a variety of perimeters depending on the orientation of the viewer, as shown in Figure 6C there is an asymmetric perimeter because the left side has a continuous curve and the right side has a plurality of additional projections and recesses)
a plurality of screw holes 122 extending through the central body from an outer surface of the central body (Figures 6A-D), wherein the plurality of screw holes are configured to receive a bone screw 114 to provide fixation for the prosthesis in a bone of a subject (abstract Figures 3A-B), and
wherein the plurality of screw holes are asymmetrically spaced in the reference plane around the outer surface of the central body (see explanation with respect to claim 1 and the 112 rejections above), and
wherein the prothesis is not mirrored from a left side to a right side across a reflection plane in the longitudinal axis and the lateral axis (see explanation with respect to claim 1 above) .
13. Angibaud discloses a first screw hole of the plurality of screw holes is configured to receive a first bone screw, wherein the first bone screw has a first screw length, the first screw length defined by a first distance from the central body to an outermost end of the first screw,
a second screw hole of the plurality of screw holes is configured to receive a second bone screw, wherein the second bone screw has a second screw length, the second screw length defined by a second distance from the central body to an outermost end of the second screw, wherein the second screw length is less than the first screw length
(Neither claims 12 or 13 positively claim the screws, and the openings of Angibaud are fully configured to receive any length of screw as long as the diameter is such that it fits within the openings).
16. Angibaud discloses a fixation site configured to receive a peg (the central opening within 112 is fully capable of receiving an appropriately sized peg, but any of the other openings can also be used with a peg of the appropriate size).
17. Angibaud discloses at least one of the bone screws has an oblique angle with respect to the reference plane (It is noted the claim does not positively claim the screws, but it is shown in Figure 8C).
18. Angibaud discloses the bone screws each have an oblique angle with respect to the reference plane and the oblique angles are different (Figure 8C and see explanation with respect to claim 7 above).
19. Angibaud discloses the central body is dimensioned for implantation into a glenoid of a subject (abstract).
21. Angibaud discloses the prosthesis comprises at least one of: four screw holes, or five screw holes, or six screw holes or is a modular prosthesis (clearly shown in Figures 6A and 8C see explanation with respect to claim 10 above).
23. Angibaud discloses a glenosphere (Figures 5A-C) coupled to the central body for use with a reverse shoulder arthroplasty (Figures 4AB).
29. Angibaud discloses at least one of the plurality of projections is a screw 114 (Figures 8A-C).
30. Angibaud discloses the perimeter follows an asymmetric contour of the bone of a side of the subject (Figure 6C shows the perimeter includes a left side that is capable of matching an asymmetric contour of the bond of a subject).
31. Angibaud discloses a back of the implant is shaped in an asymmetric manner (Figure 6C shows the implant is asymmetric).
32. Angibaud discloses the perimeter has a nonlinear shape (Figures 6A-D show the perimeter at all orientations is rounded and curved to have a non-linear shape).
Response to Arguments
Applicant's arguments filed 10/09/2025 have been fully considered but they are not persuasive.
With respect to the prior art the applicant argues that the component of Angibaud does not include an asymmetrical perimeter. This is not persuasive because as explained above orientation and configuration of the implant when viewing the implant is not defined by the claim. As seen in Figure 6C, the perimeter defined by the side profile is not symmetrical and therefore is asymmetrical. Therefore the prior art still anticipates claim 1.
With respect to claim 12 the applicant presents the same argument, so it also fails to overcome the updated prior art rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER D PRONE whose telephone number is (571)272-6085. The examiner can normally be reached Monday-Friday 10 am - 6 pm (HST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie R Tyson can be reached on (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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CHRISTOPHER D. PRONE
Primary Examiner
Art Unit 3774
/Christopher D. Prone/Primary Examiner, Art Unit 3774