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 .
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Claims 25-27 have been withdrawn from consideration.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The previous objections directed at the asymmetric screw hold spacing of claims 1 and 12 have been withdrawn in view of the applicant’s amendments.
However, the drawings remain objected to under 37 CFR 1.83(a). Figure 4E is objected to as being inconsistent with its description within the specification. New Figure 4E includes reference numbers S3/S4 and argues that it is a different embodiment than that shown in Figure 4D. [0040] describes this embodiment as being asymmetric, but neither the original specification nor the original Figure supports the specific recitation that the distances S3 and S4 make it asymmetric. This is considered new matter because there is no way to tell if the original figure was drawn to scale or is just representative. There is no support enabling us to take specific measurements or compare similar distances bases on the original disclosure. Therefore the new Figure 4E has not been entered. Furthermore, as previously stated a quick review of Figure 4E would lead one to thinking the entire implant is symmetrically shaped.
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.
Specification
The amendment filed 05/06/2026 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: as explained above the reference to newly added distances S3 and S4 are considered to be new matter because there is no clear indication that the drawings are drawn to scale or that they were intended to allow for specific dimensions to be measured therefrom. Therefore the portion of the amendment to the specification directed at Figure 4E has not been entered.
Claim Rejections - 35 USC § 112
The previous 112 rejections have been withdrawn in view of the applicant’s amendments and arguments. However it is noted that because of the complex irregular curvature of these types of implants and the broad scope of the claim language the longitudinal axis can be placed anywhere along the plane as long as it is normal to a plane that extends through the central body. Furthermore the plane can be angled or rotated in an infinite number of ways as long as it extends through at least a portion of the central body.
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.
Claims 1, 2, 6-8, 10, 12, 13, 16-19, 21, 23, and 29-32 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 claim(s) contains 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.
Independent claims 1 and 12 have both been amended to define “the longitudinal axis defining an axis of orientation for the screw holes”, which is considered to be new matter. A quick review of the elected embodiment shown in Figures 4D-E, shows that the originally disclosed longitudinal axis 430 is not consistent with the orientation of the screw holes. Clearly the axis of the first hole 410, 480, does not have the same orientation as 430 and the same can be said for the second hole 410 even without a specific axis provided.
Information Disclosure Statement
The information disclosure statement filed on 05/06/2026 has been considered by the examiner.
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.
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 as long as they extend through a portion of 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 lateral axis defining a major axis of the central body (any axis of rounded body with complex curves can qualify as a major axis, it just depends on the viewing angle and orientation of the object), the central body having an asymmetric perimeter when viewed toward an articular surface of the central body (the body of Angibaud has a variety of different shaped perimeters depending on the orientation of the viewer, this recitation has been broadened by the applicant because now it only requires the asymmetry to be present when viewing the articular surface, as shown in Figures 6B or 6D there is an asymmetric perimeter because the sides and thickness have a continuous curve providing for additional projections and recesses, this would be even more exaggerated if the body was tilted upward and twisted/rotated further)
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), the longitudinal axis defining an axis of orientation for the screw holes (the plurality of oriented longitudinal axis of Angibaud read upon this limitation as much as the applicant’s own elected embodiment, see 112 rejection above), the plurality of screw holes being asymmetrically spaced with respect to the longitudinal axis (identifying the lower central hole and the upper right hold shown in Figure 6B provides for screw holes being spaced asymmetrically positioned about an axis positioned closer to the top row of screw holes),
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 (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 as long as they extend through a portion of 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 lateral axis defining a major axis of the central body (any axis of rounded body with complex curves can qualify as a major axis, it just depends on the viewing angle and orientation of the object), the central body having an asymmetric perimeter when viewed toward an articular surface of the central body (see explanation with respect to claim 1 above)
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 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), the longitudinal axis defining an axis of orientation for the screw holes (identifying the lower central hole and the upper right hold shown in Figure 6B provides for screw holes being spaced asymmetrically positioned about an axis positioned closer to the top row of screw holes), the plurality of screw holes being asymmetrically spaced with respect to the longitudinal axis (identifying the lower central hole and the upper right hold shown in Figure 6B provides for screw holes being spaced asymmetrically positioned about an axis positioned closer to the top row of screw holes), 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 (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 other than being directed at the articular surface which as explained above allows for even extreme angles and orientations, 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.) .
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 05/06/2026 have been fully considered but they are not persuasive.
The examiner wants to make the record clear that in its current form the axis, plane, and asymmetric perimeter are open to very broad interpretations. As explained above, because of the complex irregular curvature of these types of implants and the broad scope of the claim language the longitudinal axis can be placed anywhere along the plane as long as it is normal to a plane that extends through the central body. Furthermore the plane can be angled or rotated in an infinite number of ways as long as it extends through at least a portion of the central body. Furthermore the applicant has substantially broadened the requirement addressing the asymmetric perimeter of the central body. The perimeter need only appear to be asymmetric when viewed from at least one perspective and this perspective just needs to be “towards” the articular surface. The perspective need not be normal to the surface because one is still looking towards the surface when off to an extreme angle.
With respect to the prior art the applicant argues that the component of Angibaud does not include an asymmetrical perimeter “when viewed toward an articular surface of the body.” This is not persuasive because as explained above the asymmetrical limitation has been broadened because it is now only required when viewed at a huge variety of angles and perspectives. The orientation and configuration of the implant when viewing at the articular surface would still allow for extreme angles to look at the articular surface. Rotating and twisting the implant of Angibaud will inherently make the perimeter appear asymmetrical because it will add in additional curves, thicknesses, and shapes. This can be demonstrated by taking a standard domino, which is symmetrical when looking straight on normal to the front surface, and twisting/rotating it up and to the right. After the rotation and twisting we are still viewing the front surface but now the perimeter is no longer a symmetrical rectangle, its is now more of aa asymmetrical rhombus.
Conclusion
THIS ACTION IS MADE FINAL. 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 CHRISTOPHER D PRONE whose telephone number is (571)272-6085. The examiner can normally be reached Monday-Friday 10 am - 6 pm (HST).
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 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
Prosecution Insights