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 Objections
Claims 1, 3, 5-6, 9, 11, 13, 16, 18, 20 are objected to because of the following informalities:
Claims 1 and 16 are objected to for referring to “other patients on which the arthoplasty procedure has been performed” but this is unclear, since a surgical procedure can only be performed once on one patient. If a similar procedure or the same type of procedure is performed on different patients, it would not actually be the same procedure. Accordingly, reference to “the arthoplasty procedure” being doing on other patients is unclear.
Claims 3 and 18 are objected to for referring to “a reference atlas” when the claim from which this depends has already established “at least one reference atlas of the plurality of reference atlases”. It is unclear how, if at all, these two reference atlases of the plurality relate to one another.
Claims 5 and 20 are objected to for referring to “bone models of the plurality of reference atlases” with improper antecedent basis.
Claim 6 is objected to for referring to “bone models of the plurality of reference atlases” with improper antecedent basis.
Claim 9 is objected to for referring to each “pair” of candidate implant size and implant alignment when there is no “pair” of these in the claimed invention.
Further, the claim is unclear since it is unknown how, if at all, these “candidate implant sizes and implant alignments” relate back to the previously claimed “one or both of an implant size and an implant alignment”.
The claim is further unclear for referring to “a respective reference atlas” of the plurality, making it unclear how this relates, if at all, to the previously claimed “at least one reference atlas” of the plurality.
Claim 11 is unclear for claiming “having the determined implant size at the determined implant alignment”. It is believed the phrase “at the” might be incorrect.
Claim 13 is unclear for claiming selecting “a talar implant size and/or a talar implant size”.
Appropriate correction is required.
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 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)(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.
Claim(s) 1-12, 14-20 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Mahfouz (US 20170143494 A1).
Regarding claim 1 Mahfouz discloses a method comprising:
obtaining by one or more processors (see [0246]-[0248], [0263]-[0264] etc.: the discussion of the method refers to virtual models, atlas logs, statistical automated measurements and reconstructions, input data, and modules, all of which are understood to be components which are integral to a computerized method, which is understood to inherently include a processor to perform these method tasks) a target atlas of a particular patient ([0246]) on which an arthoplasty procedure is to be performed ([0561]),
selecting by the processor, based on a comparison of values of the target atlas and a plurality of reference atlases of other patients on which the procedure has been performed, at least one reference atlas ([0248], [0263]-[0264] the atlas of the patient is compared to the statistical atlas module of the population, and the closest statistical 3d bone model is identified), and
determining by the processor and based on the selected reference atlas, an implant size or alignment for the patient ([0264] the atlas which is most similar to the patient’s bone is selected (that which aligns best with the patient); [0299]-[0303] the statistical atlas module is matched to the patient’s 3d bone module based on anatomical features and automatic landmarking and surface/shape analysis is performed to output a finite number of implants including implant families and sizes).
Regarding claims 2 and 8 Mahfouz discloses the method of claim 1 substantially as is claimed,
wherein Mahfouz further discloses selecting two reference atlases ([0269] the system can select the atlas that most closely relates to the detected deficiencies (those with similar shape, clinical appearance, or other characteristics) to generate the solution that addresses any of those deficiencies. See also [0264] and [0252] a plurality of atlases are selected before the final atlas is determined).
Regarding claim 3 Mahfouz discloses the method of claim 1 substantially as is claimed,
wherein Mahfouz further discloses selecting the reference atlas most similar to the target atlas ([0263]-[0264]).
Regarding claim 4 Mahfouz discloses the method of claim 1 substantially as is claimed,
wherein Mahfouz further discloses the target atlas includes a bone model of the patient ([0246]), and
wherein the reference atlases include a bone model of the other patients ([0248]).
Regarding claim 5 Mahfouz discloses the method of claim 4 substantially as is claimed,
wherein Mahfouz further discloses comparing the bone model of the target and reference atlases ([0248]).
Regarding claim 6 Mahfouz discloses the method of claim 5 substantially as is claimed,
wherein Mahfouz further discloses registering the model of the target and reference atlases ([0264]).
Regarding claim 7 Mahfouz discloses the method of claim 6 substantially as is claimed,
wherein Mahfouz further discloses aligning axes of the bone model and reference atlas ([0264] alignment of the bones is understood to include alignment of at least one axis of each of the bone model and reference atlas, if they are to align as the description says).
Regarding claim 9 Mahfouz discloses the method of claim 8 substantially as is claimed,
wherein Mahfouz further discloses determining a plurality of candidate implant sizes and implant alignments, wherein each pair of size/alignment corresponds to a reference atlas ([0264] the atlas which is most similar to the patient’s bone is selected (that which aligns best); [0299]-[0303] the statistical atlas module is matched to the patient’s 3d bone module based on anatomical features and automatic landmarking and surface/shape analysis is performed to output a finite number of implants including implant families and sizes; [0269] the system can select the atlas that most closely relates to the detected deficiencies (those with similar shape, clinical appearance, or other characteristics) to generate the solution that addresses any of those deficiencies. See also [0264] and [0252] a plurality of atlases are selected before the final atlas is determined).
Regarding claim 10 Mahfouz discloses the method of claim 1 substantially as is claimed,
wherein Mahfouz further discloses outputting a graphical representation of the determined implant size or alignment for display ([0246] if the reconstructed anatomy is visualized, the implant size or alignment is also considered to be displayed, see also Figure 22).
Regarding claim 11 Mahfouz discloses the method of claim 1 substantially as is claimed,
wherein Mahfouz further discloses generating virtual guidance to guide a surgeon in preparing bone for an implant with the determined size/alignment ([0398]).
Regarding claim 12 Mahfouz discloses the method of claim 1 substantially as is claimed,
wherein Mahfouz further discloses the arthoplasty is for an ankle ([0561]).
Regarding claim 14 Mahfouz discloses the method of claim 1 substantially as is claimed,
wherein Mahfouz further discloses the arthoplasty is for a shoulder ([0561]).
Regarding claim 15 Mahfouz discloses the method of claim 14 substantially as is claimed,
wherein Mahfouz further discloses selecting a glenoid or humeral implant size ([0434] humeral implant can be created or utilized).
Regarding claim 16 Mahfouz discloses the method of claim 1 substantially as is claimed,
wherein Mahfouz further discloses a computing system that includes memory (see [0246]-[0248], [0263]-[0264] etc.: the discussion of the method refers to virtual models, atlas logs, statistical automated measurements and reconstructions, input data, and modules, all of which are understood to be components which are integral to a computerized method, which is understood to inherently include a memory to perform these method tasks).
Regarding claim 17 Mahfouz discloses the method of claim 16 substantially as is claimed,
wherein Mahfouz further discloses selecting two reference atlases ([0269] the system can select the atlas that most closely relates to the detected deficiencies (those with similar shape, clinical appearance, or other characteristics) to generate the solution that addresses any of those deficiencies. See also [0264] and [0252] a plurality of atlases are selected before the final atlas is determined).
Regarding claim 18 Mahfouz discloses the method of claim 16 substantially as is claimed,
wherein Mahfouz further discloses selecting the reference atlas most similar to the target atlas ([0263]-[0264]).
Regarding claim 19 Mahfouz discloses the method of claim 16 substantially as is claimed,
wherein Mahfouz further discloses the target atlas includes a bone model of the patient ([0246]), and
wherein the reference atlases include a bone model of the other patients ([0248]).
Regarding claim 20 Mahfouz discloses the method of claim 16 substantially as is claimed,
wherein Mahfouz further discloses comparing the bone model of the target and reference atlases ([0248]).
Claim Rejections - 35 USC § 103
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 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 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 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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mahfouz as is applied above in view of Poltaretskyi et al. (US 20190380792 A1) hereinafter known as Poltaretskyi.
Regarding claim 13 Mahfouz discloses the method of claim 12 substantially as is claimed,
but is silent with regards to selecting a talar implant size.
However, regarding claim 13 Poltaretskyi teaches that a talus implant can be used within ankle arthoplasty ([0158]). Mahfouz and Poltaretskyi are involved in the same field of endeavor, namely implants. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the method of Mahfouz so that the implant size selected for the ankle arthoplasty procedure of Mahfouz is a talus as is taught by Poltaretskyi since this is one of the bones understood to make up the ankle, and so its replacement during arthoplasty is considered obvious to the person of ordinary skill.
Conclusion
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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774
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