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 .
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.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because it contains legal phraseology (i.e. “wherein” and “thereto”). A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure is objected to because of the following informalities:
a. In paragraph [0003], line 1, “veterinary surgical procedural” should read “veterinary surgical procedure”
b. In paragraph [0003], line 1, “with a goal of” should read “with the goal of”
c. In paragraph [0004], lines 3-5, “That is, the ball is formed as a projection from the long bone located between the hip and the knee thereby providing a ball to rotate within the socket or acetabulum of the hip, thereby allowing the hip to move freely.” This is a run-on sentence with two “thereby” clauses. Clarification would be better if broken into two sentences.
d. In paragraph [0004], lines 3-5, “located between the hip and knee thereby providing a ball to rotate within the socket or acetabulum of the hip, thereby allowing the hip to move freely” should include a period and read as “… the hip. Thereby allowing…”
e. In paragraph [0010], line 1, “relates the use of a spherical implant” should read “relates to the use of a spherical implant”
f. In paragraph [0021], line 1, “relates a femoral head ostectomy implant” should read “relates to a femoral head ostectomy implant”
g. In paragraph [0022], lines 3-6, "Cylindrical shelf 20 is formed between the upper and lower portions 14, 16 of the passageway and provides a seat for either a washer 30 (through which a screw 32, as shown in FIG. 7, passes) or a screw 32 in fastening the implant 10 to the veterinary patient" should be broken up into other sentences.
Appropriate correction is required.
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.
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 1 is rejected under 35 U.S.C. 103 as being unpatentable over Hargittai et al. (US 10828167) and further in view of Case et al. (US 9718241).
Hargittai et al. discloses a veterinary surgical method comprising the steps of:
removing a femoral head from a femur (see Col. 5, lines 3-8 disclosing the excision method).
Hargittai et al. fails to disclose inserting an implant into an acetabulum;
securing the implant to the acetabulum; and
placing the femur against the implant.
Case et al. also discloses an acetabular shell (10) that is hemispherically shaped to match the socket and is affixed and embedded into an acetabulum (see Col. 12, lines 54-58 disclosing the structure and function of the shell (10)). Case et al. teaches securing the shell (10) by drilling a bone screw (48) through an aperture (46) in order to align with specific areas around the acetabulum; and the head of the femoral prothesis articulates against the acetabular liner (28/30) inherently replicating the natural hip joint function (see Col. 12, lines 54-62 disclosing how the acetabular shell (10) is secured and placed against the femur). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided Hargittai et al.’s apparatus and method for a canine or other animal hip pathology, wherein an acetabular shell (10) is inserted into and secured to the natural acetabulum using bone screws (48) as taught by Case et al. Doing so would provide a means to move the buffer from the femur to the acetabulum in order to achieve the same pain-reduction goal with potentially better stability.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Hargittai et al. (US 10828167) as applied to claim 1 above, in view of Case et al. (US 9718241) and further in view of Longobardi (US 10583012).
Hargittai et al. in view of Case et al., discloses the method of claim 1, but fails to disclose wherein: the implant is spherical and the step of securing the implant to the acetabulum comprises inserting a screw into a passageway in the implant and screwing the screw into the acetabulum.
Longobardi also discloses a glenosphere component (300) that has a spherical body (see Col. 10, lines 4-18 disclosing the glenosphere and its components; Figs. 3A-3C illustrating the glenosphere (300) having varied shapes). Longobardi teaches a central passageway (324) extending through the spherical body of the glenosphere (300) to allow for a fastener to pass through it in order to secure the implant to the acetabulum (see Col. 10, lines 21-26 disclosing the central passageway). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the buffer of Hargittai et al., as modified by Case et al., with a spherical body with a central passageway for a fastener to pass through as taught by Longobardi. Doing so would provide a veterinary hip implant that is spherical (for smooth articulation), fixed to the socket for stability and utilizes a passageway to secure the implant while preventing hardware impingement.
Claim(s) 3-5, and 8-11 are rejected under 35 U.S.C. 103 as being unpatentable over Hargittai et al. (US 10828167) and further in view of Longobardi (US 10583012).
Regarding claims 3-5, and 8-11, Hargittai et al. in view of Longobardi, discloses a veterinary implant including:
a body (see Col. 12, lines 4-8 disclosing the buffer (210) implant). Hargittai et al. fails to disclose
a passageway through an axis of the spherical body, including a first length of a first diameter and a second length of a second diameter, thereby forming a shelf;
an attachment device extending through the body and into an acetabulum of a veterinary patient to attach the implant to the patient; wherein: the body is spherical; wherein: the body includes a flat portion; wherein: the attachment device extends through the passageway; wherein: the attachment device comprises a screw; wherein the shelf is sized to engage an underside of a head of the screw; and further comprising a washer positioned between the underside of the head of the screw and the shelf.
Longobardi also discloses a glenosphere component (300) that has a spherical body, a baseplate (100) forming a flat portion of the implant, and a passageway (324) (see Col. 10, lines 4-18, lines 39-44 disclosing the glenosphere and its components; Figs.1B and 3A-3C illustrating flat portion of the baseplate (100) and the glenosphere (300) having varied shapes). Longobardi teaches a central passageway (324) has a larger opening at the articulating surface and a smaller diameter within the fastener shaft, which inherently would require the use of a washer to prevent the inner shelf from deformation as it extends through the spherical body of the glenosphere (300) in order to secure the implant to the acetabulum (see Col. 10, lines 21-26 disclosing the central passageway; Fig. 1C illustrating the passageway (324) having distinct diameters at either end, which inherently creates an internal shelf which engages the underside of the head of the screw, and a chamber (124) where the fastener sits). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided Hargittai et al.’s buffer (210) for a hip joint, wherein a spherical body with a central passageway has a stepped internal diameter to allow a fastener to seat flushed within the implant as taught by Longobardi. Doing so would provide a means to insert a screw through a central passageway and hide it within the implant in order to ensure the femur can move smoothly against the implant without catching on metal hardware.
Claim(s) 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Hargittai et al. (US 10828167) as applied to claim 4 above, in view of Longobardi (US 10583012) and further in view of Case et al. (US 9718241).
Hargittai et al. in view of Longobardi, discloses the implant of claim 4, furthermore Hargittai et al. also discloses wherein: the body comprises silicone (see Col. 7, lines 35-41 disclosing the use of other biocompatible materials (e.g., silicone) for the buffer/cushion (110)); but fails to disclose wherein: the body comprises high density polyethylene.
Case et al. also discloses an acetabular shell (10) has an inner layer (14) that acts as the articulating bearing made of a biocompatible polymer (see Col. 3, lines 25-34 disclosing the materials used). Case et al. teaches that by using a specific polymer layer, the entire acetabular shell (10) can achieve an effective stiffness, which mimics the natural modulus of the pelvis in order to reduce the risk of bone loss (see Fig. 10 illustrating low stiffness of the polymer relative to thickness). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the surgical context of Hargittai et al., as modified by Longobardi, with biocompatible materials as taught by Case et al. Doing so would provide a hip implant with structural stability and low friction articulation by utilizing any type of biocompatible material (e.g., silicone).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEFAN BRADLEY CAMPBELL whose telephone number is (571)272-3498. The examiner can normally be reached Monday - Friday 7:30am-5:00pm.
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/STEFAN BRADLEY CAMPBELL/Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799