DETAILED ACTION1
REJECTIONS UNDER 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.
(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 8-16 & 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. 2007/0118243 to Schroeder.
Claim 8 recites a device [having] one or more processors communicatively coupled to…one or more memories to perform a series of method steps. As such, claim 8 is reciting a device with processors that are capable, with modification, of performing the recited method steps. Since virtually any computer can be modified with software to perform the recited method steps, the claim is anticipated by the computer systems of Schroeder. See Schroder Fig. 1. Claims 9-14 merely further refine the intended uses and thus also do no add any patentable weight.
If claim 8 were amended to recite that the processors are “configured” to perform the method steps, then the claims would be interpreted as requiring a processor that can perform the method steps without additional modification. In the interest of expedited prosecution, claims 8-14 have been alternately rejected below as if claim 8 recited the word ‘configured.’
Claim 8 recites a device and a non-transitory computer-readable medium storing instructions both that are designed to perform a series of method steps related to designing an orthopaedic implant. Schroder relates to such a system as well. See Schroeder [0002]. Schroeder teaches receiv[ing] profile information associated with a patient. See Schroeder Fig. 2A, box S1. Figure 2A further teaches receiv[ing] CT and MRI imaging (steps S4, S5) which are three-dimensional rendering[s] of a bone of the patient. Claim 8 then recites generat[ing], from the three-dimensional rendering, a structural representation of the bone. Schroeder teaches processing the image data in step S13 to create a 3D CAD model of the patient. See Schroeder [0010]. Schroder further teaches determin[ing], based on the structural representation, a placement for an orthopaedic implant relative to the bone. See Schroeder [0050]-[0054]. Specifically, Schroeder teaches iteratively performing virtual surgery, which would be inferred to include placement location of the implant. See Schroeder [0053]. Claim 8 then recites determin[ing], from the profile information, a performance characteristic for the orthopaedic implant. The term performance characteristic is highly broad and vague, but claim 11 defines one example to be an ability of the combination of the bone and the orthopaedic implant to withstand a threshold level of force. Schroeder teaches the design is created to include “internal structures such as honeycombs [and] struts]…to provide ideal structural rigidity.” See Schroeder [0054]. Schroeder also teaches selecting materials from a selection of strong metal allows. See Schroeder [0039]. Thus, the design is made to ensure the implant [can] withstand a threshold level of force. (This also anticipates claim 11.)
Next, claim 8 recites determin[ing], using an implant customization model, a data representation of the orthopaedic implant based on the structural representation and the placement, [such that] the implant customization model is configured to optimize the performance characteristic by iteratively adjusting [a] physical feature or material…to improve support for expected mechanical loads. Again, Schroeder teaches iteratively changing both the digital design and surgical plan until the design and plan and deemed acceptable. See Schrouder [0053]-[0054]. Changing the design to withstand a level of force also improve[s] support for expected mechanical loads. Finally, claim 8 recites perform[ing] an action associated with the data representation to permit the orthopaedic implant to be formed in the form of fabricating the implant. See Schroedr [0055].
Claim 9 recites that the three-dimensional rendering is generated from images associated with a computed tomography scan of the bone. Schroeder teaches that the 3D CAD model is created using, among other data, CT scans. See Schroeder [0050]. CT stands for computed tomography. Claim 12 recites that the profile information includes at least one of: an age of the patient…a sex of the patient [or] a weight of the patient. Although not explicitly mentioned, one of ordinary skill would infer that a virtual surgery team would be made aware of such basic information as the age, sex, and weight of a patient. Also, Schroeder teaches that the struts and honeycombs are fabricated to provide desired rigidity. See Schroeder. Without an an expected load on the combination of the bone and the orthopaedic implant such a rigidity could not be calculated, thus this information would also be inferred to be presented. Regarding claim 13, Schroeder teaches the biocompatible device being fabricated may be a joint prothesis. See Schroeder [0038]. An arthroplasty implant s a formal name for a joint replacement.
Claim 14 recite that the one or more processors also must perform at least one of a list of steps. One step is provide the data representation to the manufacturing device to cause the manufacturing device to form the orthopaedic implant. Schroeder teaches such a step. See Schroeder [0054]-[0055].
Claims 15-16 and 18-20 recites substantially the same features as claims 8-9 and 11-14, respectively, and are rejected for the same reasons.
REJECTIONS UNDER 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 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious2 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2007/0118243 to Schroeder in view of WO 2010/099360 to Mahfouz.3
Claim 10 recites that the structural representation is indicative of a bone structure of the bone and further teaches that when generating the structural representation, the system determine[s] respective graphical values of voxels of the three-dimensional rendering; convert[s] the respective graphical values to corresponding property values for the structural representation; and generate[s] the structural representation from the corresponding property values, wherein the structural representation is indicative of a bone structure of the bone. Schroeder teaches creating 3D models but does not explicitly teach this particular method. But it would have been obvious to modify Schroeder to perform these steps in view of Mahfouz. Mahfouz also relates to creating virtual 3D models of patient bone structures prior to surgery in order to fabricate positioning jigs. See Mahfouz [0002]-[0004]. As such, Mahfouz is analogous art to Schroeder. Mahfouz specifically teaches creating 3D reconstructions of the bone structures using conversion to create 3D points based on the 2D contours of radiagraphy scans and then processing the data. See Mahfouz [0103]-[0105]. The 3D points referred to in Mahfouz are voxels and the method of Mahfouz performs the recited steps. Id. It is obvious to apply a known technique to a known product or method, ready for improvement, to yield predictable results. See MPEP 2143(D). In this case, it would have been obvious to use this known technique for 3D optimization from Mahfouz within the method and system of Schroeder. The results would have been predictable because both are imaging human bones and tissues to create 3D models for surgical positioning. Claim 17 recites substantially the same features as claim 10 and is rejected for the same reasons.
RESPONSE TO ARGUMENTS
Applicant's arguments filed December 10, 2025 have been fully considered. Each of applicant’s remarks is set forth, followed by examiner’s response.
The 101 rejections are overcome based on the amendment reciting that the device performs an action…to cause the…implant to be formed.
Applicant’s arguments regarding the prior art rejections are unpersuasive, however. First, applicant did not amend claim 8 to recite that the processors are “configured” to perform the recited steps. As such, the initial rejection arguing that all of the recited steps are mere intended use that the processor can be modified to perform remains in effect.
Second, applicant’s arguments regarding Schroeder are also unpersuasive. Applicant argues that Schroeder merely teaches that a clinician only iteratively performs the virtual surgery, but no modifications are made to the underlying design. This argument is unpersuasive because Schroeder explicitly states “until a final digital design and surgical plan are made.” See Schroeder [0053] (underline added). Thus, the digital design is modified by the “steps” that are being repeated. Modifying the digital design invokes iteratively performing the third step of the process discussed in [0052]. The steps in [0052] involve changing materials and structural integrity, which in turn affects the ability to withstand mechanical loads. Thus, Schroeder anticipates the amended claim language.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication should be directed to Moshe Wilensky whose telephone number is 571-270-3257. Mr. Wilensky’s supervisor, Sunil Singh can be reached at 571-272-3460. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Examiner interviews are available via telephone or video conferencing using a USPTO supplied web-based collaboration tool. Applicant may also use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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/MOSHE WILENSKY/
Primary Examiner, Art Unit 3726
1 The following conventions are used in this office action. All direct claim quotations are presented in italics. All non-italic reference numerals presented with italicized claim language are from the cited prior art reference. All citations to “specification” are to the applicant’s published specification unless otherwise indicated. The use of the phrase “et al.” following a reference is used solely to refer to subsequent modifying references, and not to other listed inventors of the cited reference.
2 Hereafter all uses of the word “obvious” should be construed to mean “obvious to one of ordinary skill in the art at the time the invention was filed.”
3 Mahfauz is the WIPO publication of EP 2400934 submitted in applicant’s IDS and was submitted as the document of record with the IDS. No copy of this document is therefore provided.