DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
This communication is in response to the amendment received on 05/20/2026. Claims 1-15 remain pending in this application.
Specification
New Matter
The amendment filed 05/20/2026 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows:
The added material which is not supported by the original disclosure is as follows: The newly added recitation of “a second dimension, size, or shape of a portion of a second patient's anatomy” and “calculate one or more second adjustments to be made to the one or more dimensions of the adjustable mechanical surgical instrument” within claims 1, 10,14 appears to constitute new matter. In particular, Applicant does not point to, nor was the Examiner able to find, any support for a “a second dimension, size, or shape of a portion of a second patient's anatomy” and “calculate one or more second adjustments to be made to the one or more dimensions of the adjustable mechanical surgical instrument” feature within the specification as originally filed. As such, Applicant is respectfully requested to clarify the above issues and to specifically point out support for the newly added limitations in the originally filed specification and claims.
Applicant is required to cancel the new matter in the reply to this Office action.
Claims 2-9, 11-13, and 15 incorporate the deficiencies of independent claims 1, 10 and 14, through dependency, and are also rejected.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In particular, claim 1 has been amended to recite “determine at least one of a second dimension, size, or shape of a portion of a second patient's anatomy; and calculating and performing one or more second adjustments to be made to the one or more dimensions of the adjustable mechanical surgical instrument to fit the adjustable mechanical surgical instrument to the portion of the second patient's anatomy”-claim 1, “analyze additional patient-specific information to determine at least one of a second dimension, size, or shape of a portion of a second patient's anatomy; and calculate one or more second adjustments to be made to the one or more dimensions of the adjustable mechanical surgical instrument to fit the adjustable mechanical surgical instrument to the portion of the second patient's anatomy”-claim 10, “analyze additional patient-specific information to determine at least one of a second dimension, size, or shape of a portion of a second patient's anatomy; and calculate one or more second adjustments to be made to the one or more dimensions of the adjustable mechanical surgical instrument to fit the adjustable mechanical surgical instrument to the portion of the second patient's anatomy; and adjust the adjustable, mechanical surgical instrument based on the one or more calculated second adjustments”-claim 14.
These added features are not described in the specification and its’ not clear whether they represent a second surgical plan for a second patient or secondary adjustment for the surgical plan for the first patient.
Claims 2-9, 11-13, and 15 incorporate the deficiencies of independent claims 1, 10 and 14, through dependency, and are also rejected.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-9 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In particular, claim 1 has been amended to recite “the one or more adjustments comprise a distance between the plurality of legs, and the adjustable mechanical surgical instrument”, and it’s unclear what kind of distance is the distance between the plurality of legs and the adjustable mechanical surgical instrument. It’s unclear whether this distance corresponds to the distance between the legs or the distance between each leg to the surgical instrument. The current specification recites “For example, the planning data region may include a pin distance data value 1130. This value may specify the distance between legs 1120a and 1120c and between legs 1120a and 1120b. The ordering surgeon may adjust the physical instrument used during surgery to achieve this distance by adjusting the two arms 1122a, 1122b of the instrument 1118 to the specified pin distance value, e.g., "107.7".” on page 20, lines 7-12. There is no indication or description in the current specification about a distance between the plurality of legs and the surgical instrument.
Claims 2-9 inherit the deficiencies of claim 1 through dependency and are therefore also rejected.
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 1-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
Claims 1-9 are drawn to a method, which is within the four statutory categories (i.e. process). Claims 10-13 are drawn to a system, which is within the four statutory categories (i.e. machine). Claims 14-15 are drawn to a non-transitory medium (media), which is within the four statutory categories (i.e. manufacture).
Step 2A, Prong 1:
Claims 1, 10 and 14 have been amended to recite “analyzing patient-specific information to determine at least one of a dimension, a size, or a shape of a portion of a patient's anatomy; calculating and performing one or more adjustments to be made to one or more dimensions of an adjustable mechanical surgical instrument to fit the adjustable mechanical surgical instrument to the portion of the patient's anatomy, and wherein the calculating is based on the at least one of the dimension, the size, or the shape determined through the analyzing patient-specific information”, “analyzing additional patient-specific information to determine at least one of a second dimension, size, or shape of a portion of a second patient's anatomy; and calculating and performing one or more second adjustments to be made to the one or more dimensions of the adjustable mechanical surgical instrument to fit the adjustable mechanical surgical instrument to the portion of the second patient's anatomy”.
The limitations of “analyzing patient-specific information to determine at least one of a dimension, a size, or a shape of a portion of a patient's anatomy; calculating …one or more adjustments to be made to one or more dimensions of an adjustable mechanical surgical instrument to fit the adjustable mechanical surgical instrument to the portion of the patient's anatomy, and wherein the calculating is based on the at least one of the dimension, the size, or the shape determined through the analyzing patient-specific information”, “analyzing additional patient-specific information to determine at least one of a second dimension, size, or shape of a portion of a second patient's anatomy; and calculating … one or more second adjustments to be made to the one or more dimensions of the adjustable mechanical surgical instrument to fit the adjustable mechanical surgical instrument to the portion of the second patient's anatomy” are directed to an abstract idea of “certain methods of organizing human activity”, based on managing personal behavior and interactions between people regarding analyzing and calculating adjustments to be made to one or more dimensions of an adjustable mechanical surgical instrument based on the patient-specific information. The mere nominal recitation of a generic processors and generic memories does not take the claims out of the methods of organizing human interactions grouping. Thus, the claims recite an abstract idea.
The limitations of “analyzing patient-specific information to determine at least one of a dimension, a size, or a shape of a portion of a patient's anatomy; and calculating … one or more adjustments to be made to one or more dimensions of an adjustable mechanical surgical instrument to fit the adjustable mechanical surgical instrument to the portion of the patient's anatomy, and wherein the calculating is based on the at least one of the dimension, the size, or the shape determined through the analyzing patient-specific information” also correspond to a “mental process”, since these steps also can be performed in human mind or human using pen and paper.
The limitation of “performing one or more adjustments/second adjustments to be made to one or more dimensions of an adjustable mechanical surgical instrument to fit the adjustable mechanical surgical instrument to the portion of the patient's anatomy” corresponds to insignificant application (see the section below).
Claim 2 recites “generating an electronic surgical plan for the patient utilizing at least one electronic data file or electronic object corresponding to the patient's anatomy, the electronic surgical plan including instructions for performing the surgical procedure on the patient, where the instructions are customized to the patient, and specify the one or more adjustments to be made to the adjustable mechanical surgical instrument to fit the adjustable mechanical surgical instrument to the portion of the patient's anatomy; displaying, on a computer display, at least a portion of the electronic surgical plan including the one or more adjustments to be made to the adjustable mechanical surgical instrument and displaying a visual representation of the adjustable mechanical surgical instrument that is visually docked to an exterior of a visual representation of the portion of the patient's anatomy” and the limitations of “generating an electronic surgical plan for the patient utilizing at least one electronic data file or electronic object corresponding to the patient's anatomy, the electronic surgical plan including instructions for performing the surgical procedure on the patient, where the instructions are customized to the patient, and specify the one or more adjustments to be made to the adjustable mechanical surgical instrument to fit the adjustable mechanical surgical instrument to the portion of the patient's anatomy” is directed to an abstract idea of “certain methods of organizing human activity” with a recitation of generic computing component (generating an electronic surgical plan using a generic processor). This limitation also is directed to managing personal behavior and interactions between people, therefore an abstract idea of certain methods of organizing human activity.
Claims 2-9, 11-13 and 15 are ultimately dependent from claims 1, 10, 14 and include all the limitations of claims 1, 10, 14. Therefore, claims 2-9, 11-13 and 15 recite the same abstract idea. Claims 2-9, 11-13 and 15 describe a further limitation regarding the basis for determining and generating a surgical plan for the patient. These are all just further describing the abstract idea recited in claims 1, 10, 14, without adding significantly more.
After considering all claim elements, both individually and in combination and in ordered combination, it has been determined that the claims do not amount to significantly more than the abstract idea itself.
Step 2A, Prong 2:
This judicial exception is not integrated into a practical application. In particular, claims recite the additional elements of “one or more memories storing patient-specific information; and one or more processors in communicating relationship with the one or more memories, the one or more processors configured to: analyze the patient-specific information to determine at least one of a dimension, a size, or a shape of a portion of the a patient's anatomy, calculate… one or more adjustments to be made to one or more dimensions of an adjustable mechanical surgical instrument;…”, which are hardware and software elements, these limitations are not enough to qualify as “practical application” being recited in the claims along with the abstract idea since these elements are merely invoked as a tool to apply instructions of the abstract idea in a particular technological environment, and mere instructions to apply/implement/automate an abstract idea in a particular technological environment and merely limiting the use of an abstract idea to a particular field or technological environment do not provide practical application for an abstract idea (MPEP 2106.05(f) & (h)).
Claims also recite other additional limitations beyond abstract idea, including functions such as storing data from/to a database, displaying/notifying data are insignificant extra-solution activities and “performing one or more adjustments/second adjustments to be made to one or more dimensions of an adjustable mechanical surgical instrument to fit the adjustable mechanical surgical instrument to the portion of the patient's anatomy” which corresponds to an insignificant application (see MPEP 2106.05 (g)), which do not provide a practical application for the abstract idea.
Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claims are directed to an abstract idea.
Step 2B:
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using a processor to perform both the analyzing information and calculating adjustments steps amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept.
The claims are not patent eligible.
Response to Arguments
Applicant's arguments filed 05/20/2026 have been fully considered. Applicant’s arguments will be addressed below in the order in which they appear.
Argument about 35 USC 101 rejection:
Applicant argues that claims include additional elements that are sufficient to amount to significantly more than the purported abstract idea and physical adjustment of a surgical instrument in patient-specific manner is not directed to insignificant application.
In response, Examiner submits that the performing one or more adjustments described in the present specification as “The ordering surgeon may adjust the physical instrument used during surgery to achieve this distance by adjusting the two arms 1122a, 1122b of the instrument 1118 to the specified pin distance value, e.g., "107.7.” on page 20, lines 10-12, which indicates the surgeon (user) adjusts the surgical instrument after the surgical plan is created. This feature corresponds to an insignificant application, since the limitation is insignificant. The MPEP recites an additional element is insignificant extra-solution activity, when the limitation is significant (i.e. it imposes meaningful limits on the claim such that it is not nominally or tangentially related to the invention) (see MPEP § 2106.05(g)).
Therefore, the argument is not persuasive and claims 1-15 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Argument about 35 USC 102/103 rejection:
The argument about 35 USC 102/103 rejections is persuasive and the rejections have been withdrawn.
Conclusion
THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DILEK B COBANOGLU whose telephone number is (571)272-8295. The examiner can normally be reached 8:30-5:00 ET.
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/DILEK B COBANOGLU/Primary Examiner, Art Unit 3687
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