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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/25/2025 has been entered.
Priority
This application claims priority from provisional application 62/457,327 filed 02/10/2017
Status of Claims
Claims 1-3, 5, 6, 9-13, and 22-29 are pending.
Claims 4, 7, 8, and 14-21 have been cancelled.
Claims 11, 26, 27, and 29 have been withdrawn from consideration.
The applicant is advised that should the pending claims be placed in condition for allowance, the withdrawn dependent claims need to be amended to replace solid core portion with solid core layer. Additionally claim 29 will need substantial amendments to bring it to be consistent in scope with the remaining claims.
Election/Restrictions
Applicant elected Species 2 (Figures 2) and Species B (Figures 2B) without traverse on 07/02/2024.
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, an embodiment with each of the outer porous layer, the solid core layer, and the at least one core chamber extending from the first end to the second end of the hybrid segment; (Claims 1 and 12 see 112 rejection below) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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 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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 1-3, 5, 6, 9, 10, 12, 13, 22-25, and 28 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 been amended to require “each of the outer porous layer, the solid core layer, and the at least one core chamber extending from the first end to the second end of the hybrid segment”, which is considered to be new matter. The drawings show numerous possibilities for cross-sections for the hybrid segment, but they are always indicated at a middle location of the hybrid segment. However, nowhere within the original disclosure does the specification say that this cross-section is what is within the entire hybrid segment or that it extends from the first end to the second end. The specification specifically identifies the inner structures, but repeatedly defines them as “extending longitudinally through at least a portion of the stem portion”. This does not provide support for them to extend from the first end to the second end of the hybrid segment
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) 1-3, 5, 6, 9, 10, 12, 22-25, and 28 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wallick USPN 8,998,987 B2.
1. Wallick discloses femoral component 10 of a prosthetic hip implant (Figure 4), the femoral component comprising:
a neck portion 14; and
a stem portion (below the flange in Figure 4) including a proximal end (top) and a distal end (bottom), wherein the neck portion extends from the proximal end (Figure 4), wherein the distal end comprises a tip (adjacent 22 Figure 4), and the stem portion comprises at least two distinct longitudinal stem segments including:
a solid segment (bottom wide portion 22 in Figure 4) including the distal end of the stem portion (bottom adjacent 22 in Figure 4); and
a hybrid segment (multilayered portion in Figure 4) extending from a first end adjacent to the neck portion to a second end adjacent to the solid segment (Figure 4 shows the hybrid section stars at the top of tip 22 and extends up to the neck portion 14) and including:
an outer porous layer 30 defining an outer surface of the hybrid segment (Figure 4) and including a plurality of pores (7:3-8),
a solid core layer without pores 31s (7:3-8) circumscribed by the outer porous layer (Figure 4), and
at least one core chamber 31p (the examiner is identifying the core chamber as the area filled by layer 31p, it is the space occupied by 31p and defined by the inner surface of 31s, not the actual material within it) circumscribed by the solid core layer (Figure 4) the core chamber comprising a single longitudinal aperture defined by an inner surface of the solid core layer (the core chamber is the entire volume within layer 31s);
wherein each of the outer porous layer, the solid core layer, and the at least one core chamber extend from the first end to the second end of the hybrid segment (Figure 4 shows a complete cross-section with all layers and chambers extending the full length)
wherein the femoral component comprises a unitary component (8:35-37) that is formed by additive manufacturing of the femoral component from a 3D model of the femoral component (the use of additive manufacturing from a 3D model amounts to a product by process limitation. Whether a product is patentable depends on whether it is known in the art or it is obvious, and is not governed by whether the process by which it is made is patentable. Product by process claims are not construed as being limited to the product formed by the specific process recited. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process (see MPEP 2113). In this case the implant of Wallick is fully capable of the widely known practice of 3D printing).
2. Wallick discloses an outer portion of the solid segment is smooth (22 is an extension of 20 which is defined as being solid 7:16-18 Figure 4 ).
3. Wallick discloses the hybrid segment includes at least two core chambers circumscribed by the solid core layer (Wallick discloses a first chamber defined by and circumscribed by layer 31s, Wallick also discloses a second inner most chamber defined by the inner surface of layer 28, the chambers are concentric with layer 31s making them inherently circumscribed by the solid core layer Figure 4).
5. Wallick discloses the hybrid segment includes at least one porous core layer circumscribed by the solid core layer (Wallick discloses layer 31p is porous 7:3-8 and circumscribed by layer 31s Figure 4).
6. Wallick discloses the hybrid segment includes the core chamber (surrounding 31p) and at least one of a second core chamber (inner chamber surrounding 20) or a porous core laver (31p) circumscribed by the solid core laver (Figure 4).
9. Wallick discloses the stem portion is tapered from the proximal end to the distal end (Figure 4 shows the tapered outer shape).
10. Wallick discloses the stem portion has a cross- sectional profile that is trapezoidal-shaped, rectangular-shaped, oval-shaped, circular-shaped, or teardrop-shaped (Figure 8 shows the rectangular shaped cross-section).
12. Wallick discloses a prosthetic hip implant comprising 10 (Figure 4):
a femoral ball H; and
a femoral component 12 comprising:
a neck 14 configured to connect to the femoral ball (Figure 4); and
a stem (below neck in Figure 4) including a proximal end (top) and a distal end (bottom), wherein the neck extends from the proximal end (Figure 4), wherein the distal end comprises a tip (adjacent 22 Figure 4), and the stem comprises
a solid segment (bottom wide portion 22 in Figure 4) including the distal end of the stem portion (bottom adjacent 22 in Figure 4); and
a hybrid segment (multilayered portion in Figure 4), extending from a first end adjacent to the neck portion to a second end adjacent to the solid segment (Figure 4 shows the hybrid section stars at the top of tip 22 and extends up to the neck portion 14) and including:
an outer porous layer 30 defining an outer surface of the hybrid segment (Figure 4) and including a plurality of pores (7:3-8),
a solid core layer without pores 31s (7:3-8) circumscribed by the outer porous layer (Figure 4), and
a core chamber 31p (the examiner is identifying the core chamber as the area filled by layer 31p, it is the space occupied by 31p and defined by the inner surface of 31s, not the actual material within it) circumscribed by the solid core layer (Figure 4), at least one of a second core chamber (inner chamber surrounding 20), a porous core layer (31p) or a second solid core layer (layer 20) circumscribed by the solid core laver (Figure 4), the core chamber comprising a single longitudinal aperture defined by an inner surface of the solid core layer (the core chamber is the entire volume within layer 31s);
wherein each of the outer porous layer, the solid core layer, the core chamber and the at least one second core chamber extend from the first end to the second end of the hybrid segment (Figure 4 shows a complete cross-section with all layers and chambers extending the full length)
wherein the femoral component comprises a unitary component (8:35-37) that is formed by additive manufacturing of the femoral component from a 3D model of the femoral component (the use of additive manufacturing from a 3D model amounts to a product by process limitation. Whether a product is patentable depends on whether it is known in the art or it is obvious, and is not governed by whether the process by which it is made is patentable. Product by process claims are not construed as being limited to the product formed by the specific process recited. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process (see MPEP 2113). In this case the implant of Wallick is fully capable of the widely known practice of 3D printing).
22. Wallick discloses the hybrid segment further includes the second solid core layer circumscribed by the solid core layer (20 Figure 4).
23. Wallick discloses the hybrid segment further includes the second core chamber that is circumscribed by the solid portion (inner chamber surrounding 20).
24. 25. Wallick discloses the hybrid segment further includes a first porous core layer (31p Figure 4) and a second porous core layer (28 Figure 4, is described as being less porous than 30 but still porous 7:4-5) which are both circumscribed by the solid core layer 31s.
28. Wallick discloses the stem is tapered from the proximal end to the distal end (Figure 4 shows the tapered outer shape).
Claim Rejections - 35 USC § 103
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) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wallick in view of Kennedy et al (Kennedy) USPN 5,360,446 A.
Wallick discloses the invention substantially as claimed being described above. However, Wallick does not disclose the use of an acetabular shell with the femoral implant.
Kennedy teaches the use of a femoral implant further including an acetabular shell (86 Figure 4A) in the same field of endeavor for the purpose of reinforcing the acetabular side of the joint.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide the acetabular shell of Kennedy within femoral implant of Wallick in order to strengthen and restore acetabular side of the joint.
Response to Arguments
The request for an interview has been denied at this time because the examiner has no questions for the applicant.
Applicant's arguments filed 10/31/2025 have been fully considered but they are not persuasive. As an initial note, the examiner did not agree that the most recent amendments would overcome all outstanding rejections. As stated in the interview summary the final wording was not arranged and the current claims are substantially different than the proposed claims. The applicant has not presented any clear arguments with respect to the prior art within the after final amendment of the request for continued examination. However, for clarity sake, the claims have been amended to replace the inner hollow non-porous core portion with a core chamber. Wallick discloses numerous circumferential layers making up his hybrid segment of the stem. The inner layers are positioned within chambers defined by the outer layers. Therefore Wallick clearly discloses a plurality of core chambers that read upon the claims.
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).
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Christopher D. Prone/Primary Examiner, Art Unit 3774