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 62/457,327 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Claims 11, 26, 27, and 29 have been withdrawn from consideration.
Election/Restrictions
Applicant elected Species 2 (Figures 2) and Species B (Figures 2B) without traverse on 07/02/2024.
Drawings
The objections to the drawings have been withdrawn in view of the applicant’s amendments.
Claim Rejections - 35 USC § 112
The previous 112 rejections have been withdrawn in view of the applicant’s amendments.
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 (the examiner is identifying a single pore of layer 31p) circumscribed by the solid core layer (Figure 4 shows the solid core layer circumscribes the entire layer 31p including the single pore);
the core chamber comprising a single longitudinal hollow aperture (each pore of the porous layer 31p is considered to be a single longitudinal opening) extending longitudinally through at least a portion of the hybrid segment (the pores extend in all directions because they are three dimensional and Figure 4 shows them within the hybrid segment) and defined by an inner surface of the solid core layer (the solid core layer is considered to further comprise the solid portion of 31p surrounding the pore);
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 shows the solid core layer circumscribes the entire layer 31p including the single pore), and
a core chamber (the examiner is identifying a single pore of portion 31p as the core chamber) circumscribed by the solid core layer (Figure 4), at least one of a second core chamber (any other pore of portion 31p), a porous core layer (the rest of 31p) or a second solid core layer (layer 20) circumscribed by the solid core laver (Figure 4), the core chamber comprising a single longitudinal hollow aperture (each pore of the porous layer 31p is considered to be a single longitudinal opening) extending longitudinally through at least a portion of the hybrid segment (the pores extend in all directions because they are three dimensional and Figure 4 shows them within the hybrid segment) and defined by an inner surface of the solid core layer (the solid core layer is considered to further comprise the solid portion of 31p surrounding the pore);
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
Applicant's arguments filed 10/31/2025 have been fully considered but they are not persuasive.
The applicant argues that past prosecution has included arguments over hollow versus porous, but those remarks did not highlight that the specification recites various alternatives for the composition of the disclosed longitudinal chambers 252 as being "porous, hollow, or alternatively, formed of a different solid material. This argument does not limit any pore of a porous structure from being called hollow. The specification provides both hollow and porous as options but fails to define what would and would not qualify as either. As long as a pore of a porous section is hollow it would qualify as hollow.
The applicant goes on to say that while the application may not define "porous" it does use the terms porous and hollow as alternative structures. Accordingly, it is not within the broadest reasonable interpretation in view of the specification to consider a structure defined by the art as "porous" as anticipating the presently recited "hollow aperture." This is not persuasive because providing a positive example does not support a limiting or negative limitation. The specification is silent as to what would and would not qualify as porous and hollow. Therefore, we are left to the broadest reasonable interpretation of the terms.
Then the applicant argues that since the specification calls out a "hollow" structure as an alternative to a "porous" structure makes the argument that a hollow structure is just a porous structure with a single pore incompatible with any reasonable interpretation of the claim language in light of the specification. This is also not persuasive because there is no factual evidence showing a commonly accepted definition or a specific definition within the original disclosure disqualifying this type of interpretation. A hollow chamber according to the broadest reasonable interpretation is simply a structure having an unfilled or hollowed-out space within (Merriam Webster). A Porous structure according to the broadest reasonable interpretation is simply a structure having pores (Merriam Webster). Accordingly, a pore would qualify under the broadest reasonable definition of a hollow chamber as long as it is empty.
The applicant further argues that Wallick does not utilize the term "hollow", but it does utilize the term "non-porous" as well as describing degrees of porosity (e.g., less porous) in describing what a person of ordinary skill in the art would consider to be hollow. This is not persuasive because as explained above an empty pore which would be present in even the least porous structure would meet the requirement for a hollow chamber.
Finally, the applicant argues that Wallick does not disclose a hybrid segment including a "core chamber comprising a single longitudinal hollow aperture extending longitudinally through at least a portion of the hybrid segment". This is not persuasive because as explained above the portion 31p includes pores which each qualify as a core chamber comprising a single longitudinal hollow aperture. Regardless of the final shape of the pore because they are three dimensional they inherently extend out in every direction from their center. This would include extending longitudinally through at least a portion of the hybrid segment. Since the claims fail to define the actual shape of the chamber, any dimensions, or the extent it extends, even the smallest pore will inherently extend a small amount anticipating the claim language.
In order to advance prosecution the applicant is advised to better define the specific relationship between the circumscribing solid layer and the chambers as being in direct contact about the entire outer surface of the core chamber, to better define the dimensions/shapes of the chambers to be bigger than pores, and to better define the core chamber position relative to the second chamber/porous core layer/second solid core layer.
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 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
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