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 .
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-9, 20, 21 and 24 are rejected under 35 U.S.C. 102(a)(2) as being (a)(2) by Ball US patent Pub. 2019/0046326A1.
Ball discloses a method of providing a humeral implant (100, see Fig. 1), comprising developing an initial manufacturing plan for making at least a patient-specific humeral anchor (see paragraph 58, lines 1-4) of the humeral anchor based on glenohumeral joint information of a specific patient, the initial manufacturing plan including a virtual humeral implant (see paragraph 115) including a virtual patient-specific humeral anchor (140). Performing a biomechanical analysis of a shoulder configured with the virtual humeral implant (See paragraphs 85-106). Determining a final manufacturing plan for making at least the patient-specific humeral anchor of the humeral anchor based on the biomechanical analysis; and manufacturing the patient-specific humeral anchor of the humeral implant following the final manufacturing plan (See paragraph 115).
Regarding claim 2, see paragraph 115 disclosing the additive manufacturing.
Regarding claim 3, see element (160) as the integrated locking device, see paragraph 63.
Regarding claim 4, see Figs. 1-6, element 126 and proximal end of element (140) are wider than distal end of shaft (140).
Regarding claim 5, see paragraphs 100 and 101 disclosing the optimization of bone impingement and soft tissue tensioning and compression.
Regarding claim 6, the reference discloses a pre-operative planning system including generating a virtual 3D model of a humeral implantable joint reflecting one or more claimed parameters (paragraph 115) and analysis shown in paragraphs 85-106. These biomechanical analysis include modifying one or more inclination angle, center of rotation offset, version angle, tensioning dimension, metaphysis transverse size, articular surface offset, inlay depth, jump distance , etc..
Regarding claim 7, the Examiner has not given examining weight to the language of the angle range of 125 to 160 degrees since, there is an “or”. Look at paragraphs 6,7 and 57 disclosing the adjusting of inclination to reduce impingement and/or dislocation.
Regarding claim 8, there is also another or in the claim, therefore, lines 3 and 4 have not been examined. Regarding the adjusting the center of rotation offset, see figure below showing that the center of rotation of the concave surface is offset to the longitudinal axis of the stem.
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Regarding claim 9, paragraph 111 discloses that the optimized parameters can reflect one or more optimized parameters, therefore, the Examiner is interpreting that the step of modifying the center of rotation offset can be done at least twice in order to optimize the prosthetic device.
Regarding claim 20, see Fig. 10 showing how the inlay depth (height of the implant extending beyond the resection of the bone). The reference does not specifically mentions how high the implant extends beyond the resected bone but it is inherently shown that the implant extends a couple of millimeters and does not exceed 20mm.
Regarding claim 21, this is the whole purpose of the system optimization, the system is capable of running hundreds of simulations in order to find the optimized inlay depth based on a fit of a metaphysis portion within the humerus and as disclosed in paragraph 101 the system conduct soft tissue analysis.
Regarding claim 24, see paragraphs 99 and 111.
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.
Claims 10-19, 22 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Ball US patent Pub. 2019/0046326A1 in view of Roche et al US Patent 8,870,962B2.
Ball discloses the invention substantially as claimed. However, Ball et al is not specific how the system do the biomechanical analysis modifying one or more of the center of rotation offset, the 5% of adjusting version, the Ball reference is silent regarding how they come up with the thickness of the metaphysis bowl (range between 1mm to 20mm), the lead angle (within a range of 25 to 75 degrees) is silent regarding outputting an indication to a user, the step of modifying a metaphysis transverse size (range between 33mm to 55mm) and the step of adjusting a location of a center of rotation by at least 0.5mm.
Regarding claims 10-12, as disclosed in claim 25, paragraphs 58, 82-84, the humeral implant can be customized to the given patient based on calculated pre-operative planning and analysis of the patient’s humeral diaphysis and metaphysis offset, lengths, etc.. Therefore, it would have been obvious to one ordinary skill in the art to conduct a range of motion analysis, including virtually positioning implants and obtain patient-specific values in order to find and optimize the center of rotation offset of the humeral implant. Regarding claim 11 and 12, see paragraphs 6,7,57 and the soft tissue analysis is expressly part of the planning process.
Regarding claim 13, Ball et al discloses the version of the angle by determining the angle of the adapter in order to select the most appropriate implant. However, Ball et al does not disclose the adjusting version by 5% from an initial version configuration to reduce at least one incident of bone impingement or the incident of luxation/dislocation.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to adjust the version by 5% from an initial version configuration, since it has been held that finding an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F. 2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claims 14 and 15, Ball et al discloses in step 10 and 14 in paragraphs 95 and 99 disclose a plurality of liners heights (thickness) and a soft tissue analysis assessing total soft tissue length changes and contractions for the purpose of finding the correct height of the liners, etc…
It would have been obvious to one having ordinary skill in the art at the time the invention was made to select a range of 1mm to 20mm, since it has been held that finding an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F. 2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claim 16, see Fig. 37 of the Roche et al reference showing a lead angle within the range of 25 to 75 degrees for the purpose of creating a wider angle and avoid impingement.
At the time the invention was made, it would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the lead angle of the bearing to create a wider angle because Applicant has not disclosed that by having a wider angle provides an advantage, is used for a particular purpose, or solves a stated problem. One ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the lead angle of the Roche et al reference because it would perform equally as well.
Therefore, it would have been an obvious matter of design choice to modify the Roche et al reference to obtain the invention as specified in claim 16.
Regarding claim 17, it is inherent that the system will send a notification to the user of all the dimensions and shape of the prosthetic joint in order to the user/surgeon can confirm the selected dimensions of the device.
Regarding claim 18, NOTE: the Examiner interprets the metaphysis transverse size as the diameter of liners. Therefore, Roche et al discloses in Fig. 49, three diameters of the liner having 38, 42 and 46mmin, therefore, it would have been obvious to one ordinary skill in the art at the time the invention was made to select a range of 33mm to 55mm, since it has been held that finding an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F. 2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claim 19, as disclosed in paragraphs 96-101 the system is capable of selecting the optimized size, shape of the implant for the purpose of customizing the patient’s specific joint. However, the references do not disclose the step of adjusting a center of rotation by at least 0.5mm of the an articular surface offset.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to adjust the location of a center of rotation by at least 0.5mm of an articular body, since it has been held that finding an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F. 2d 272, 205 USPQ 215 (CCPA 1980).
aragraphs 95 and 99 disclose a plurality of liners heights (thickness) and a soft tissue analysis assessing total soft tissue length changes and contractions for the purpose of finding the correct height of the liners, etc…
It would have been obvious to one having ordinary skill in the art at the time the invention was made to select a range of 1mm to 20mm, since it has been held that finding an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F. 2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claims 22 and 23, as disclosed in paragraphs 96-101 the system is capable of selecting the optimized size, shape of the implant for the purpose of customizing the patient’s specific joint. However, the references do not disclose the step of adjusting a jump distance between two portions of a superior edge of the articular body. NOTE: see Fig. 49 disclosing different liners with different heights between two portions of the superior edge of each liner.
It would have been obvious to one having ordinary skill in art at the time the invention was made to adjust a jump distance difference between two portions of a superior edge of the articular body, since it has been held that finding an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F. 2d 272, 205 USPQ 215 (CCPA 1980).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALVIN J STEWART whose telephone number is (571)272-4760. The examiner can normally be reached Monday-Friday 8:30AM-6PM EST.
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/ALVIN J STEWART/Primary Examiner, Art Unit 3799 9/28/26
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