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 .
Election/Restrictions
Applicant’s election without traverse of the election/restriction in the reply filed on February 2, 2026 is acknowledged.
Applicant has elected Group III: Claims 11-18, drawn to a method of designing a guidance specific to a patient.
Claims 1-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on February 2, 2026.
Claims 1-18 are presently pending in this application.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 11-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) “the method comprising: designing a reamer guidance configured to guide reaming of a humerus; designing a first humeral guidance interference-fitted with the reamer guidance and having a surface tailored to a humerus head; designing a second humeral guidance having a surface tailored to an intertubercular groove of the humerus head; and designing a cutting guidance mutually coupled to the reamer guidance, the first humeral guidance, and the second humeral guidance” stated in claim 11, “comprising, before the designing of the reamer guidance, the first humeral guidance, the second humeral guidance, and the cutting guidance, receiving image information about a body part of a target patient; performing 3D modeling based on the received image information; and providing a 3D modeling manufacturing function of a patient-customized medical device based on information about the 3D modeling” stated in claim 12, “wherein the designing of the reamer guidance configured to guide reaming of the humerus and the designing of the cutting guidance mutually coupled to the reamer guidance, the first humeral guidance, and the second humeral guidance include displaying, to an operator, predetermined specification information of the reamer guidance and predetermined specification information of the cutting guidance for selection” stated in claim 13, “further comprising: when the operator inputs the specification information of the reamer guidance and the cutting guidance, and feedback information of the designed first humeral guidance and the designed second humeral guidance, modifying the design of the guidance based on the specification information of the reamer guidance and the cutting guidance, and the feedback information of the first humeral guidance and the second humeral guidance that are input by the operator” stated in claim 14, “further comprising: designing a positioning pin guidance configured to guide a position of an implant on a cut surface of a humerus that is subjected to cutting; and designing a rail guidance configured to be seated on the positioning pin guidance, and having a hole provided for fixing and coupling the rail guidance to a periphery of a head of the humerus that is subjected to cutting” stated in claim 15, “comprising, before the designing of the positioning pin guidance and the rail guidance, receiving image information about a body part of a target patient; performing 3D modeling based on the received image information; and providing a 3D modeling manufacturing function of a patient-customized medical device based on information about the 3D modeling” stated in claim 16, “wherein the designing of the positioning pin guidance configured to guide the position of the implant on the cut surface of the humerus, and the designing of the rail guidance configured to be seated on the positioning pin guidance and having the hole provided for fixing and coupling the rail guidance to the periphery of the head of the humerus that is subjected to cutting includes displaying, to an operator, predetermined specification information of the positioning pin guidance and predetermined specification information of the rail guidance for selection” stated in claim 17, “wherein the designing of the rail guidance configured to be seated on the positioning pin guidance and having the hole provided for fixing and coupling the rail guidance to the pe1iphery of the head of the humerus that is subjected to cutting includes: inputting, by an operator, positions of a plurality of holes provided for fixing and coupling the rail guidance to the periphery of the head of the cut humerus, pin insertion angles of the holes, and hole depths of the holes, modifying the design of the guidance based on information about the positions of the plurality of the holes, the pin insertion angles of the holes, and the hole depths of the holes that are input by the operator”. This judicial exception is not integrated into a practical application because the claim(s) recites a mental process when it contains limitation(s) that can practically be performed in the human mind, including, for example, observations, evaluations, judgments, and opinions. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The claim(s) is not patent eligible.
Examiner’s Note
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.
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) 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kehres et al. (US 2016/0374697), herein referred to as Kehres, and in view of Khatibi et al. (US 2021/0113222), herein referred to as Khatibi.
Regarding claim 11, Kehres discloses a method of designing a guidance specific to a patient (title and Abstract), the method comprising designing a reamer guidance (610) (¶90) configured to (i.e. capable of) guide reaming of a humerus (26), designing a first humeral guidance (604) having a surface (figures 21A-21C) tailored to a humerus head (26), designing a second humeral guidance (614) having a surface (figures 21A-21C) tailored to an intertubercular groove of the humerus head (26), and designing a cutting guidance (624) mutually coupled to the reamer guidance (610), the first humeral guidance (604), and the second humeral guidance (614) (figures 21A-21C).
Yet, Kehres lacks a detailed description on the first humeral guidance interference-fitted with the reamer guidance.
However, Khatibi teaches a guide (92) (figures 4-6A) interference-fitted (e.g. press-fit, ¶74) with another guide (98A, 98B, 98C, or 98D) (figures 4-6A).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kehres’s connection between the first humeral guidance and the reamer guidance being interference-fitted as taught by Khatibi, since such a modification would provide a specific type of connection mechanism between two parts.
Regarding claim 12, the modified Kehres’s method has comprising, before the designing of the reamer guidance, the first humeral guidance, the second humeral guidance, and the cutting guidance, receiving image information about a body part of a target patient (¶36 of Kehres), performing 3D modeling (¶37 of Kehres) based on the received image information (¶37 of Kehres), and providing a 3D modeling manufacturing function of a patient-customized medical device (¶37 of Kehres) based on information about the 3D modeling (¶37 of Kehres).
Regarding claim 13, the modified Kehres’s method has wherein the designing of the reamer guidance configured to guide reaming of the humerus and the designing of the cutting guidance mutually coupled to the reamer guidance, the first humeral guidance, and the second humeral guidance include displaying (via computer, ¶36-¶39 of Kehres), to an operator (e.g. surgeon, ¶38 of Kehres), predetermined specification information of the reamer guidance (610 of Kehres) and predetermined specification information of the cutting guidance (624 of Kehres) for selection (¶38 of Kehres).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kehres and Khatibi as applied to claims above, and further in view of Khan et al. (US 2024/0252180), herein referred to as Khan.
Regarding claim 14, the modified Kehres’s method discloses all the features/elements as claimed including further comprising when the operator (e.g. surgeon, ¶38 of Kehres) inputs the specification information of the reamer guidance (610 of Kehres) and the cutting guidance (624 of Kehres), and feedback information of the designed first humeral guidance (604 of Kehres) and the designed second humeral guidance (614 of Kehres), but lacks a detailed description on modifying the design of the guidance based on the specification information of the reamer guidance and the cutting guidance, and the feedback information of the first humeral guidance and the second humeral guidance that are input by the operator.
However, Khan teaches modifying a design of a guidance (e.g. patient specific guide) based on the specification information (¶194, ¶195, figure 4) that are input by the operator (e.g. a user can adjust, ¶195).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the modified Kehres’s method with modifying the design of the guidance based on the specification information as taught by Khan, since such a modification would enable a user to adjust dimensions/information before manufacturing (¶195).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SI MING KU whose telephone number is (571)270-5450. The examiner can normally be reached Monday-Friday, 9:30am-6pm.
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, Kevin Truong can be reached at (571)272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SI MING KU/Primary Examiner, Art Unit 3775
Prosecution Insights