DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/01/2025 has been entered.
Claims 1-16 remain pending in this application.
This application is a continuation of application 16/740,940 (patent no. 11,482,316) and 13/225,246 (patent no. 10,540,479).
The nonstatutory double patenting rejection over claims 1-20 of U.S. Patent No. 10,540,479 has been acknowledged by the Applicant in the Remarks, dated 12/01/2025 and the Applicant will address the rejection upon the indication of allowable subject matter.
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 1-16 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, 16 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; and 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”. The limitations of “analyzing patient-specific information… and “calculating one or more adjustments to be made to one or more dimensions of an adjustable mechanical surgical instrument” 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 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 has been amended to recite “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, wherein the adjustable mechanical surgical instrument is suitable for reuse with different patients based on different adjustments to the adjustable mechanical surgical instrument” 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 15-16 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 15-16 recite the same abstract idea. Claims 2-9, 11-13 and 15-16 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 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.
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 pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 1-2, 4-16 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Mire et al. (hereinafter Mire) (US 7,542,791 B2).
Claim 1 has been amended to recite a method comprising:
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 (Mire discloses “Patient registration is the process of determining how to 25 correlate the position of the instrument 52 on the patient 14 to the position on the diagnostic, pre-acquired, or real-time images. To register the patient 14, the physician or user will select and store particular points from the pre-acquired images and then touch the corresponding points on the 30 patients anatomy with a pointer probe 62…” in col. 11, lines 25-31); and
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 (Mire discloses “Once the procedure is determined in block 426, an implant may be selected in block 428. Selecting the implant in block 428 may include selecting an appropriate type of implant, selecting an appropriate size of an implant, including a Volume, size, geometry and other appropriate considerations and confirming that the implant may achieve selected results from the patient…Alternatively, an implant may be substantially custom designed for the procedure determined in block 426. Therefore, the implants may be preformed or formed after determining the procedure in block 426 to achieve selected results.” in col. 39, lines 14-28).
Claim 2 has been amended to recite the method of claim 1 further comprising:
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; (Mire discloses “…the instrument 52 may be any type of medical instrument or implant…. The instrument 52 may also be an orthopedic instrument, used for an orthopedic procedure. Such as reamers, impactors, cutting blocks, saw blades, drills, drill guides, distracters, awls, taps, probes, screw drivers, etc…” in col. 8, line 44 to col. 9, line 3, “Briefly, the navigation system 12 operates as follows. The navigation system 12 creates a translation map between all points in the radiological image generated from the imaging device 16 and the corresponding points in the patients anatomy in patient space. After this map is established, whenever a tracked instrument 52 is used, the work station 36 in combination with the coil array controller 48 and the controller 30 uses the translation map to identify the corresponding point on the pre-acquired image, which is displayed on dis play 10. This identification is known as navigation or localization. An icon representing the localized point or instrument is shown on the display 10, along with five or six degrees of freedom indicia.” in col. 10, lines 34-46, “To enable navigation, the navigation system 12 will detect both the position of the patient's anatomy 14 and the position of the surgical instrument 52. Knowing the location of these two items allows the navigation system 12 to compute and display the position of the instrument 52 in relation to the patient 14. The tracking system 44 is employed to track the instrument 52 and the anatomy simultaneously. While the display 10 is configured to show the instrument with six degree of freedom accuracy.” in col. 11, lines 1-9),
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, wherein the adjustable mechanical surgical instrument is suitable for reuse with different patients based on different adjustments to the adjustable mechanical surgical instrument (Mire discloses “Briefly, the navigation system 12 operates as follows. The navigation system 12 creates a translation map between all points in the radiological image generated from the imaging device 16 and the corresponding points in the patients anatomy in patient space. After this map is established, whenever a tracked instrument 52 is used, the work station 36 in combination with the coil array controller 48 and the controller 30 uses the translation map to identify the corresponding point on the pre-acquired image, which is displayed on dis play 10. This identification is known as navigation or localization. An icon representing the localized point or instrument is shown on the display 10, along with five or six degrees of freedom indicia.” in col. 10, lines 34-46).
Mire teaches “an implant may be modeled in block 430 that has been digitally augmented or digitally created” in col. 40, lines 20-24 and “…the instrument 52 may be any type of medical instrument or implant…” in col. 8, lines 48-49. Mire does not expressly teach the specific data recited in claim 1 (“wherein the adjustable mechanical surgical instrument is suitable for reuse with different patients based on different adjustments to the adjustable mechanical surgical instrument”); however, these differences are only found in the non-functional descriptive material and are not functionally involved in the steps recited nor do they alter the recited structural elements. The recited method steps would be performed the same regardless of the specific data. Further, the structural elements remain the same regardless of the specific data. Thus, this descriptive material will not distinguish the claimed invention from the prior art in terms of patentability, see In re Gulack, 703 F.2d 1381, 1385, 217 USPQ 401, 404 (Fed. Cir. 1983); In re Lowry, 32 F.3d 1579, 32 USPQ2d 1031 (Fed. Cir. 1994); MPEP 2111.05.
Claim 4 has been amended to recite the method of claim 2 wherein the electronic surgical plan further includes one or more instructions for constructing a patient-specific component for use during the surgical procedure (Mire discloses “At block 240, the data from either the image based or the image sense based pre-operative planning is analyzed. Should the data only include image data from block 238, this image data may be used to identify areas of interest, the patient size, and be used to assist in preparing the Surgical plan. …” in col. 24, lines 25-30).
Claim 5 has been amended to recite the method of claim 1 wherein the patient's anatomy includes a hip of the patient, and the one or more adjustments cause the adjustable mechanical surgical instrument to fit to the hip of the patient (Mire discloses “With each of the procedures 74 or 76, the procedure may be initially based on the use of atlas information or a 3-D model that is morphed, to be a patient specific model.…Proceeding under block 76 and assuming that the area of interest is the hip joint, an atlas model of the femur and pelvis may be the initial starting point..” in col. 13, lines 46-67).
Claim 6 has been amended to recite the method of claim 5 further comprising fitting the adjustable mechanical surgical instrument to the hip of the patient to perform the surgical procedure (Mire discloses “With each of the procedures 74 or 76, the procedure may be initially based on the use of atlas information or a 3-D model that is morphed, to be a patient specific model.…Proceeding under block 76 and assuming that the area of interest is the hip joint, an atlas model of the femur and pelvis may be the initial starting point..” in col. 13, lines 46-67).
Claim 7 has been amended to recite the method of claim 2 further comprising modifying the electronic surgical plan by an ordering surgeon (Mire discloses “A system may be used for both preoperative planning and navigation during an operative procedure. Preoperative planning may be used to plan and confirm a selected procedure and select an implant for performing the procedure. For example, though not intended to be limiting, a selected disc or nucleus implant may be selected depending upon an image acquired of a patient and various measurements, such as size, shape, Volume, location in the spine, (cervical, thoracic, lumbar), range of motion, and others, relating to the disc or nucleus to be replaced. Various other procedures may be performed with the system, Such as knee implant selection, a thermal hip stem selection and others. In addition, the system may be used to navigate and perform the procedure to ensure that the selected plan is followed to achieve a result.” in col. 2, lines 49-62).
Claim 8 has been amended to recite the method of claim 2 wherein the one or more adjustments of the surgical plan specify a setting for a guide pin for orienting a prosthetic component inserted into the patient's anatomy (Mire discloses “With the indicia of the implant/instrument 52 being dis played, the implant/instrument 52 is aligned or fixed with the target/trajectory 102 at block 124. In this regard, the tip 104 and the hind 106 are aligned and fixed relative to the target/ trajectory 102 at the origin and the rotational orientation is also aligned to the desired position…” in col. 15, lines 53-65).
Claim 9 has been amended to recite the method of claim 2 wherein the instructions include machine instructions and wherein the adjustable mechanical instrument is robotic, the method further comprising: adjusting the adjustable mechanical surgical instrument based on the adjustments and utilizing the machine instructions by the adjustable, mechanical instrument to perform the surgical procedure (Mire discloses “…a substantially automated or robotic system may be used to perform the predetermined or pre-selected Surgical plan, Substantially autonomously or with Supervision. Therefore, it will be understood that the selected or determined plan may be performed according to any appropriate method, such as with a user or with a robotic system. In addition, the robotic system may be a partial robotic system that includes a portion that is exterior to the patient or that is Substantially contained within the patient,…” in col. 44, line 65 to col. 45, line 7).
As per claims 10-13, they are system claims which repeat the same limitations of claims 1, 6, 8, 9, the corresponding method claims, as a collection of elements as opposed to a series of process steps. Since the teachings of Mire disclose the underlying process steps that constitute the methods of claims 1, 6, 8, 9, it is respectfully submitted that they provide the underlying structural elements that perform the steps as well. As such, the limitations of claims 10-13 are rejected for the same reasons given above for claims 1, 6, 8, 9.
As per claims 14-15, they are article of manufacture claims which repeat the same limitations of claims 1, 8, the corresponding method claims, as a collection of executable instructions stored on machine readable media as opposed to a series of process steps. Since the teachings of Mire disclose the underlying process steps that constitute the method of claims 1, 8, it is respectfully submitted that they likewise disclose the executable instructions that perform the steps as well. As such, the limitations of claims 14-15, are rejected for the same reasons given above for claims 1, 8.
Newly added claim 16 recites the method of claim 1, wherein the adjustable mechanical surgical instrument comprises a plurality of legs and the one or more adjustments comprise a distance between the plurality of legs (Mire discloses “…The instrument 52 may also be an orthopedic instrument, used for an orthopedic procedure. Such as reamers, impactors, cutting blocks, saw blades, drills, drill guides, distracters, awls, taps, probes, screw drivers, etc. …” in col. 8, lines 652-56 and “Once each vertebrae 200 and 202 have been distracted by the cam distracter 204, a sagittal wedge 206 also having a tracking sensor 58 is utilized and shown in FIG. 8 c. The sagittal wedge 206 is used to center each vertebrae 200 and 202, along the sagittal plane and again may be tracked and displayed with six degree of freedom on the display 10, as illustrated in FIG. 9. In this regard, the surgeon can confirm both visually and via the display 10 that the sagittal wedge 206 is centered on the sagittal plane between the vertebrae 200 and 202, as well as obtain the proper depth, via the Z axis display 86 on the display 10, illustrated in FIG. 9.” ln col. 22, lines 7-17).
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 (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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 3 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Mire et al. (hereinafter Mire) (US 7,542,791 B2) in view of Woods et al. (hereinafter Woods) (US 8,635,082 B2).
Claim 3 has been amended to recite the method of claim 2 further comprising notifying an ordering surgeon of the availability of the electronic surgical plan by at least one of an email message, a text message, or a voice message.
Mire fails to expressly teach “notifying the ordering surgeon” and “the ordering surgeon is notified by an email message…”. However, this feature is well known in the art, as evidenced by Woods. In particular, Woods discloses:
Wood discloses “…For example, the electronic approval may be embodied as an email, a predetermined response to the digital templated medical images, or any other data capable of providing notification of the approval to the implant recommendation system 40.” Wood; col. 11, lines 12-16.
It would have been obvious to one having ordinary skill in the art at the time of the invention to include the aforementioned limitation as disclosed by Wood with the motivation of obtaining an electronic authorization from the ordering surgeon (Woods; col. 14, lines 39-59).
Response to Arguments
Applicant's arguments filed 12/01/2025 have been fully considered but they are not persuasive. Applicant’s arguments will be addressed below in the order in which they appear.
Argument about 35 USC 101 rejection:
Applicant argues that the amended claims require “calculating and performing adjustments to an adjustable mechanical surgical instrument based on determined dimension, size, or shape of a portion of a patient’s anatomy…” and claims are not directed to a mental process.
In response, Examiner submits that 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. And the limitation of “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” corresponds to an insignificant application, which do not provide a practical application for the abstract idea.
Therefore, claims 1-16 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Argument about 35 USC 102 rejection:
Applicant argues that Mire does not teach adjusting the mechanical surgical instrument with adjustable dimension.
In response, Examiner submits that Mire teaches “Once the procedure is determined in block 426, an implant may be selected in block 428. Selecting the implant in block 428 may include selecting an appropriate type of implant, selecting an appropriate size of an implant, including a Volume, size, geometry and other appropriate considerations and confirming that the implant may achieve selected results from the patient…Alternatively, an implant may be substantially custom designed for the procedure determined in block 426. Therefore, the implants may be preformed or formed after determining the procedure in block 426 to achieve selected results.” in col. 39, lines 14-28. Furthermore, Mire teaches “…a screen 440 may include a display of a selected portion of the anatomy including a template program. With reference to a Sagittal plane view 442, a template shape. Such as a square 444, may be illustrated relative to the vertebrae 406, 408. Because of the modeling, various dimensions of the template shape 444, such as height, width, depth, Volume and other appropriate dimensions may be known, changed and/or adjusted. The template shape 444 may be moved, sized, and the like by a user, Such as a physician, to achieve a selected fit between the vertebrae 406, 408. Once the physician has determined that a selected or desirable shape and size has been achieved, the dimensions of the template shape 444 may be known due to the fact that the model has been substantially rendered and determined in three dimensions…” in col. 39, lines 53-67.
Therefore, the arguments are not persuasive.
Conclusion
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