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 .
CLAIM INTERPRETATION
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
Use of the word “means” (or “step for”) in a claim with functional language creates a rebuttable presumption that the claim element is to be treated in accordance with 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph) is invoked is rebutted when the function is recited with sufficient structure, material, or acts within the claim itself to entirely perform the recited function.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step for”) in a claim creates a rebuttable presumption that the claim element is not to be treated in accordance with 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph) is not invoked is rebutted when the claim element recites function but fails to recite sufficiently definite structure, material or acts to perform that function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Such claim limitations is/are:
“an imaging unit for creating at least one image of a bone arrangement comprising at least the bones in a defined orientation of the bones relative to each other;” (Claim 22)
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
“an imaging unit for creating at least one image of a bone arrangement comprising at least the bones in a defined orientation of the bones relative to each other;” (Claim 22): As identified by the Specification, the following is recognized as the corresponding structure to the imaging unit: “an imaging unit for creating at least one (patient-specific, real) image of a bone arrangement comprising at least the bones (of the joint), in particular in a defined orientation of the bones relative to each other, preferably in a defined viewing direction onto the bones, preferably an X-ray device for creating an X-ray image of the bones of the joint,” Or equivalents thereof.
If applicant wishes to provide explanation or dispute the examiner’s interpretation of the corresponding structure, applicant must identify the corresponding structure with reference to the specification by page and line number, and to the drawing, if any, by reference characters in response to this Office action.
If applicant does not intend to have the claim limitation(s) treated under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112 , sixth paragraph, applicant may amend the claim(s) so that it/they will clearly not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, or present a sufficient showing that the claim recites/recite sufficient structure, material, or acts for performing the claimed function to preclude application of 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
For more information, see MPEP § 2173 et seq. and Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162, 7167 (Feb. 9, 2011).
Claim Objections
The Claims are objected to because of the following informalities:
In Claim 26, the phrase “a display unit for displaying a graphical representation of the at least one initial dataset; and an input unit for a user, and in that characteristic landmarks and/or a joint center of the joint are settable and/or changeable by the user at the input unit, and in that corresponding information is storable in the at least one initial dataset.” Should be replaced with -- a display unit for displaying a graphical representation of the at least one initial dataset; and an input unit for a user, and characteristic landmarks and/or a joint center of the joint are settable and/or changeable by the user at the input unit, and corresponding information is storable in the at least one initial dataset. -- for claim clarity.
Corresponding changes should be made in Claims 27-29 as it is unclear how the phrase “in that” is attempting to modify the claim language.
In Claim 28, the phrase “a plurality of sample data sets assignable to a respective bone is stored in the memory unit,” Should be replaced with -- a plurality of sample data sets assignable to a respective bone are [[is]] stored in the memory unit, -- for grammatical correctness.
Appropriate correction is required and applicant should carefully review the Claims for any other informalities.
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 22-41 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.
Specifically, the Specification lacks the written description needed for “a static model data set” and “a dynamic model data set” as the necessary models/algorithms to create said model datasets are not supported with sufficient detail. Pages 15-16 of the cleaned Specification dated 3/21/2024 provide the most relevant teachings. Here there is a first teaching that a care provider may be identified by the user on the representation and a second teaching that the data processing unit performs this as an automatic determination. In the former scenario, the written description of the invention is not supported because the identification of models is performed by a user based on their judgement from given information at this later measuring time. In the latter scenario, no specific formula or models are given to create the matching between the patient’s two-dimensional X-ray image and the stored three-dimensional model, so it is unclear how a match will be made. And indicating that inputs include ‘various axes and joint centers as well as characteristic landmarks’ does not change the current black box nature of the determination.
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 22-23 and 36 and claims dependent thereon 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 pre-AIA the applicant regards as the invention.
Regarding Claim 22, the term “a pose of a joint center of a joint via which one of the bones is connected to another bone" renders the claim indefinite because it is unclear if “a joint” and “another bone” refers to the previously outlined joint and a previously outlined bone connected to the joint or if “a joint” is a new joint, distinct from the first claimed joint, and the “another bone” is a new bone connected opposite one of the previously bones and connected with a second, new joint. Appropriate changes would include -- a pose of a joint center of a second joint, different from the first joint, via which one of the bones is connected to a third bone -- and renaming the joint in line 22 as the “first joint.”
Regarding Claim 23, the term “the joint" in line 4 renders the claim indefinite because it is unclear if “the joint” refers to the outlined joint in line 2 of Claim 22 or the outlined joint in lines 22-23 of Claim 22. Appropriate changes would include -- the first joint --.
Regarding Claim 23, the term “a bone is movable via a joint on another bone" in line 5 renders the claim indefinite because it is unclear if limitation refers to the outlined second joint in lines 22-23 of Claim 22 or is introducing a new joint and new bones. Appropriate changes would include -- one of the [[a]] bones is movable via [[a]] the second joint on the third bone --.
Regarding Claim 36, the phrase “wherein, based on this, a pose of the axes of the bones, an intersection of the axes and a length of the bones are stored in the dynamic model data set” renders the claim indefinite because it is unclear what previous limitation “this” in line 1 is referring to.
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 22-41 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Regarding Claim 22, the claim(s) recites “the data processing unit being configured and programmed to computationally adapt a respective sample data set to at least one initial dataset and to provide a static model data set of the bones that is patient-individualized,
the data processing unit being configured and programmed to provide a dynamic model data set of the bones based on the static model data set and based on information of the sensor elements as a result of a movement of the bones relative to each other, wherein the dynamic model data set comprises information about a relative position and/or a relative mobility of the bones to each other, and
the relative position comprising at least one of:
an angle at which the bones are oriented to each other in a static posture;
a pose of a joint center of the joint between the bones; and
a pose of a joint center of a joint via which one of the bones is connected to another bone.” which amounts to an abstract idea (mental process and mathematical relationships).
This judicial exception is not integrated into a practical application because:
- The claims fail to outline an improvement to the technical field.
- The claims fail to apply the judicial exception to effect a particular treatment.
- The claims fail to apply the judicial exception with a particular machine.
- The claims fail to effect a transformation or reduction of a particular article to a different state or thing.
Next, the claim as a whole is analyzed to determine whether any element or a combination of elements, integrates judicial exception into a practical application.
For this part of the 101 analysis, the following additional limitations are considered:
“an imaging unit for creating at least one image of a bone arrangement comprising at least the bones in a defined orientation of the bones relative to each other;”
The additional elements are insufficient to amount to significantly more than the judicial exception because they seem to merely generally link the use of the judicial exception to a particular technological environment.
Moreover, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because they pertain merely to insignificant extrasolution data gathering activities.
Furthermore, sensing units are general field of use and data processing units and memory units are generic computer elements used to perform generic computer functions and don’t add significantly more and are well-understood, routine, and previously known to the industry.
None of these limitations, considered as an ordered combination provide eligibility because the claim taken as a whole, does not amount to significantly more than the underlying abstract idea of generating a static model data set of the patient’s bone and updating the static model data set based on changing inputs from sensor elements and does not purport to improve the functioning of the signal processing, or to improve any other technology or technical field. Use of a generic signal processing does not amount to significantly more than the abstract idea itself. Dependent claims 23-38 also do not add significantly more to the exception as they merely add details to the mental steps, add details to the extrasolution data gathering steps, add general field of use components to facilitate the extrasolution data gathering, and add mental steps.
Regarding Claim 39, the claim(s) recites “adapting, computationally via the data processing unit, of a sample data set stored in a memory unit and assignable to the respective bone, and providing a patient-individualized static model data set;
providing a dynamic model data set of the bones, which comprises information about a relative position and/or a relative mobility of the bones to each other, based on the static model data set and based on information from sensor elements as a result of a movement of the bones relative to each other.” which amounts to an abstract idea (mental process and mathematical relationships).
This judicial exception is not integrated into a practical application because:
- The claims fail to outline an improvement to the technical field.
- The claims fail to apply the judicial exception to effect a particular treatment.
- The claims fail to apply the judicial exception with a particular machine.
- The claims fail to effect a transformation or reduction of a particular article to a different state or thing.
Next, the claim as a whole is analyzed to determine whether any element or a combination of elements, integrates judicial exception into a practical application.
For this part of the 101 analysis, the following additional limitations are considered:
“creating at least one image of a bone arrangement comprising at least the bones in a defined orientation of the bones relative to each other;”
“providing, based on the at least one image, at least one initial dataset of the bones, via a data processing unit;”
The additional elements are insufficient to amount to significantly more than the judicial exception because they seem to merely generally link the use of the judicial exception to a particular technological environment.
Moreover, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because they pertain merely to insignificant extrasolution data gathering activities.
Furthermore, sensor elements are general field of use and data processing units and memory units are generic computer elements used to perform generic computer functions and don’t add significantly more and are well-understood, routine, and previously known to the industry.
None of these limitations, considered as an ordered combination provide eligibility because the claim taken as a whole, does not amount to significantly more than the underlying abstract idea of generating a static model data set of the patient’s bone and updating the static model data set based on changing inputs from sensor elements and does not purport to improve the functioning of the signal processing, or to improve any other technology or technical field. Use of a generic signal processing does not amount to significantly more than the abstract idea itself. Dependent claims 40-41 also do not add significantly more to the exception as they merely add details to the mental steps, add details to the extrasolution data gathering steps, add general field of use components to facilitate the extrasolution data gathering, and add mental steps.
Claim 40 are rejected under 35 U.S.C. 101 because the claimed invention encompasses non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because a “computer-readable storage medium” encompasses both statutory subject matter such as a random-access memory and non-statutory subject matter such as carrier waves. Examiner suggests amending the claim to read “A non-statutory computer-readable storage medium comprising commands which, when executed by a computer, cause the computer to perform steps of claim 39.”
Claim 41 are rejected under 35 U.S.C. 101 because the claimed invention encompasses non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because a “computer program” encompasses both statutory subject matter such as a random-access memory and non-statutory subject matter such as carrier waves. Examiner suggests amending the claim to read “A non-statutory computer program comprising commands which, when the computer program is executed by a computer, cause the computer to perform steps of claim 39.”
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 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.
Claim(s) 39-41 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mahfouz (US 2019/0133693) as noted in Applicant IDS dated 6/12/2024.
Regarding Claim 39, while Mahfouz teaches a medical technology method for identifying kinematics of bones of a patient connected to each other at a joint (Abstract, [0120]), comprising:
creating at least one image of a bone arrangement comprising at least the bones in a defined orientation of the bones relative to each other ([0109], [0113]-[0116], [0120]);
providing, based on the at least one image, at least one initial dataset of the bones, via a data processing unit ([0120] processing device captures sensor and bone data in X-ray images, the first capture image acting as an initial dataset);
adapting, computationally via the data processing unit, of a sample data set stored in a memory unit and assignable to the respective bone, and providing a patient-individualized static model data set ([0117]-[0120] “The reconstructed bone surfaces, along with the registered sensors in the images, may be used to initialize a motion capture session, consisting of at least one bone and sensor, that have been registered in 3D space via X-ray reconstruction of the bone and registration of the sensor to the same image(s) used for reconstruction, thus providing information relating the sensor(s) to the bone(s). Using this relative information, the sensor data may now be related to the bone data directly. In this way, static X-ray images may be used to initialize a sensor-based motion capture system and used in capturing dynamic information of the 3D joint.” an X-ray reconstruction used along with bone template models to generate a patient-specific 3D model, the presence of the bone template models in the analysis points to the models being stored data, [0107] and the system includes memory units, a required location for data storage),
providing a dynamic model data set of the bones, which comprises information about a relative position and/or a relative mobility of the bones to each other, based on the static model data set and based on information from sensor elements as a result of a movement of the bones relative to each other ([0120] “This exemplary process is illustrated in FIG. 14. In this exemplary process, X-ray and sensor data may be used together to create dynamic imaging data. This data can be utilized in a similar way as fluoroscopy dynamic data as outlined herein. After the motion capture session is initialized, joint motion activities may be performed. During each activity, the orientation data from each sensor is relayed to the processing device and recorded. The processing device may provide some visual indication of the motion being performed, such as updated 3D renderings of the bone models in their respective positions determined using the sensor data. Here dynamic data encompasses at least a bone model, a sensor model, their relative positions and orientations, and time-stamped data relating to the motion of the bone during at least one activity (quaternions, rigid transformations, or any other as dictated by the sensor capabilities).” [0143], [0147], [0149]-[0150] a dynamic model data set of the bones based on the static model data set and based on information of the sensor elements as a result of a movement of the bones relative to each other can be used to evaluate an implant placement and determine whether satisfactory results can be achieved),
Regarding Claim 40, Mahfouz teaches a computer-readable storage medium comprising commands which, when executed by a computer, cause the computer to perform steps of claim 39 (See Claim 39 Rejection, [0008], [0015], [0105] software used which comprises commands to perform steps of claim 39).
Regarding Claim 41, Mahfouz teaches a computer program comprising commands which, when the computer program is executed by a computer, cause the computer to perform steps of claim 39 (See Claim 39 Rejection, [0008], [0015], [0105] software used which comprises commands to perform steps of claim 39).
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.
The factual inquiries 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.
Claim(s) 22-31, 34, and 37-38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mahfouz in view of Lang (US 2021/0192759).
Regarding Claim 22, while Mahfouz teaches a medical device system for identifying kinematics of bones of a patient connected to each other at a joint (Abstract, [0120]), the medical device system comprising:
an imaging unit for creating at least one image of a bone arrangement comprising at least the bones in a defined orientation of the bones relative to each other ([0011] radiographic image taking machine, [0104] x-ray instrumentation [0109], [0113]-[0116], [0120]);
a data processing unit configured and programmed to provide at least one initial dataset of the bones based on the at least one image ([0120] processing device captures sensor and bone data in X-ray images, the first capture image acting as an initial dataset);
a memory unit ([0107] the system includes memory units, a required location for data storage) and the analysis has access to at least one sample data set assignable to a respective bone ([0117]-[0120] an X-ray reconstruction used along with bone template models to generate a patient-specific 3D model, the presence of the bone template models in the analysis, specific to different bones, indicates the models being stored data); and
a sensor unit with sensor elements that are arrangeable in a defined spatial relationship to the respective bone on a part of the patient comprising the bones ([0107], [0109], [0113]-[0116], [0120] tracking sensors fixed to the patient such as IMUs, accelerometers, gyroscopes, magnetometers),
the data processing unit being configured and programmed to computationally adapt a respective sample data set to at least one initial dataset and to provide a static model data set of the bones that is patient-individualized ([0120] “The reconstructed bone surfaces, along with the registered sensors in the images, may be used to initialize a motion capture session, consisting of at least one bone and sensor, that have been registered in 3D space via X-ray reconstruction of the bone and registration of the sensor to the same image(s) used for reconstruction, thus providing information relating the sensor(s) to the bone(s). Using this relative information, the sensor data may now be related to the bone data directly. In this way, static X-ray images may be used to initialize a sensor-based motion capture system and used in capturing dynamic information of the 3D joint.”),
the data processing unit being configured and programmed to provide a dynamic model data set of the bones based on the static model data set and based on information of the sensor elements as a result of a movement of the bones relative to each other, wherein the dynamic model data set comprises information about a relative position and/or a relative mobility of the bones to each other ([0120] “This exemplary process is illustrated in FIG. 14. In this exemplary process, X-ray and sensor data may be used together to create dynamic imaging data. This data can be utilized in a similar way as fluoroscopy dynamic data as outlined herein. After the motion capture session is initialized, joint motion activities may be performed. During each activity, the orientation data from each sensor is relayed to the processing device and recorded. The processing device may provide some visual indication of the motion being performed, such as updated 3D renderings of the bone models in their respective positions determined using the sensor data. Here dynamic data encompasses at least a bone model, a sensor model, their relative positions and orientations, and time-stamped data relating to the motion of the bone during at least one activity (quaternions, rigid transformations, or any other as dictated by the sensor capabilities).” [0143], [0147], [0149]-[0150] a dynamic model data set of the bones based on the static model data set and based on information of the sensor elements as a result of a movement of the bones relative to each other can be used to evaluate an implant placement and determine whether satisfactory results can be achieved), and
the relative position comprising at least the assessment of an anatomical axis ([0139]-[0140] the assessment of an anatomical femoral axis),
Mahfouz fails to explicitly teach the at least one sample data set assignable to a respective bone is stored in the memory unit.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, for the memory unit of Mahfouz to act as a storage location for sample data sets of Mahfouz as a teaching that standardizes the reference model information may be accessed, thus ensuring consistency across applications of the invention.
Mahfouz fails to teach the relative position comprising at least one of:
an angle at which the bones are oriented to each other in a static posture;
a pose of a joint center of the joint between the bones; and
a pose of a joint center of a joint via which one of the bones is connected to another bone.
However Lang teaches a surgical feedback device utilizing kinematic information of a patient’s joints and bones (Abstract, [0360], [0429]-[0437]) comprising
an imaging step for creating at least one image of a bone arrangement comprising at least the bones in a defined orientation of the bones relative to each other ([0429]);
a sensor unit with sensor elements that are arrangeable in a defined spatial relationship to the respective bone on a part of the patient comprising the bones ([0432] tracking information can be derived from multiple bones),
determining the relative position of a pose of a joint center of the joint between the bones based on imaging data ([0433] where Mahfouz teaches that a pose is a “a current position and orientation” in [0105]. Because a center point does not exhibit an orientation, determining the current position of a joint center should fulfill the claim limitation) as part of placing an implant for mechanical axis correction of a lower extremity ([0437]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, for an anatomical axis assessment of Mahfouz to be further utilized as an intermediate step in a mechanical axis correction as taught in Lang as a way to increase the utility of Mahfouz’s surgical planning by also utilizing the anatomical axis assessment for mechanical axis correction (Lang: [0360]).
Regarding Claim 23, Mahfouz and Lang teach the medical device system according to claim 22, wherein the relative mobility comprises at least one of:
at least one angle circumference under which the bones are movable relative to each other at the joint; and
at least one angle circumference under which a bone is movable via a joint on another bone (See Claim 22 Rejection, the characterizing information included in the dynamic model data set is relative position as outlined in the previous rejection. While this claim adds to how relative mobility should be understood, it does not positively claim that the information of the dynamic model data set must include now relative mobility. Thus the claim language has still been met by the previous rejection).
Regarding Claim 24, Mahfouz and Lang teach the medical device system according to claim 22, wherein the imaging unit is an X-ray unit and the at least one initial dataset comprises a two-dimensional representation of the bones (See Claim 22 Rejection).
Regarding Claim 25, Mahfouz and Lang teach the medical device system according to claim 22, wherein the data processing unit is configured and programmed to computationally determine characteristic landmarks and/or a joint center of the joint in the at least one initial dataset and to store corresponding information in the at least one initial dataset (See Claim 22 Rejection, Lang’s joint center teaching and Mahfouz [0117] teaches that anatomical landmarks are determined computationally to align constructed 3D model with 2D images).
Regarding Claim 26, Mahfouz and Lang teach the medical device system according to claim 22, and Mahfouz further teaches the system further comprising
a display unit for displaying a graphical representation of the at least one initial dataset ([0012] the display unit is stated as showing the virtual models as feedback, and using the display for graphical representation of the at least one initial dataset is understood as intended use in this system claim); and
an input unit for a user ([0042] software user interface, [0191] where a computer is the input unit / software user interface), and
in that characteristic landmarks and/or a joint center of the joint are settable and/or changeable by the user at the input unit (Figs. 25A-25C, [0042]-[0044] the registration of anatomic landmarks corresponding between a three dimensional model and a two-dimensional x-ray image are settable by a user, [0118]), and
in that corresponding information is storable in the at least one initial dataset (See Claim 22 Rejection, [0107]).
Regarding Claim 27, Mahfouz and Lang teach the medical device system according to claim 22, and Mahfouz further teaches the system wherein the at least one initial dataset comprises a scale (Fig. 26, [0045], [0163] shows a captured radiographic image incorporates a scale) and in that the data processing unit is configured and programmed to determine axes defined by the bones and/or an angle between the bones ([0140]) and to store them in the at least one initial dataset (See Claim 22 Rejection).
Regarding Claim 28, Mahfouz and Lang teach the medical device system according to claim 22, wherein a plurality of sample data sets assignable to a respective bone is stored in the memory unit (See Claim 22 Rejection, [0117] statistical bone atlas provides a list of bone models for alignment with calculated 3D landmarks, this data would obviously be stored like the previously noted sample data sets), and in that the data processing unit is configured and programmed to identify a most suitable sample data set from the plurality of sample data sets using a static form model (See Claim 22 Rejection, [0116]-[0117]) and to adapt it to the bone ([0118] patient specific adaptation of the bone template model by optimizing the bone atlas’ principle component values).
Regarding Claim 29, Mahfouz and Lang teach the medical device system according to claim 22, wherein the at least one sample data set comprises a three-dimensional representation of the bone (See Claim 22 Rejection, [0117] the alignment of the sample datasets with 3D landmarks indicates a three-dimensional representation) and in that the data processing unit is configured and programmed to provide a three-dimensional static model data set and, based on this, a three-dimensional dynamic model data set (See Claim 22 Rejection, [0117]-[0118] X-ray reconstruction method for a three-dimensional static model data set, [0120] tracking sensors may be used along with X-ray reconstruction method to a provide a dynamic model data set based on tracked movement of the model).
Regarding Claim 30, Mahfouz and Lang teach the medical device system according to claim 22, wherein the at least one sample data set comprises information about characteristic landmarks of the bone (See Claim 22 Rejection, [0116]-[0117] characteristic landmarks of the bone are identified as landmark projection points that are 2D points in the image views that represent 3D anatomical landmarks) and the data processing unit is configured and programmed to store, in the static model data set, information about axes defined by the bones, dimensions of the bones, their lengths, characteristic landmarks, joint centers between the bones and/or an angle between the bones ([0116]-[0117] the construction of a patient-specific bone model indicates a final knowledge of the location of characteristic landmarks on the bone as this was necessary for the matching of the landmarks from the measured data and statistical data of known anatomy).
Regarding Claim 31, Mahfouz and Lang teach the medical device system according to claim 22, and Mahfouz further teaches the system wherein the sensor elements comprise or are associated with a fastening device via which the sensor elements are non- invasively attachable to body parts comprising the bones ([0120] a wrap or flexible band).
Regarding Claim 34, Mahfouz and Lang teach the medical device system according to claim 22, and Mahfouz further teaches the system wherein the data processing unit is configured and programmed to identify and store a spatial relationship of the sensor elements to the bones in the dynamic model data set based on information of the sensor elements ([0184] describes the process of identifying and storing a spatial relationship of a sensor element, which can be applied to sensor elements specific to each bones in the rejection of Claim 22).
Regarding Claim 37, Mahfouz and Lang teach the medical device system according to claim 22, and Mahfouz further teaches the system wherein the bones are a femur and a tibia of the patient ([0149]-[0155] the joint analyzed for implant placement includes the knee, [0132] where the evaluated bones around the knee are the femur and tibia), and wherein the dynamic model data set stores at least one of:
mechanical and/or anatomical femur axis and/or tibia axis;
position of a knee-joint center;
position of a hip-joint center;
position of an ankle-joint center;
varus-valgus pose of a femur and a tibia;
information on a range of motion for flexion and/or extension;
information on internal and/or external rotation of the femur and the tibia;
information on a translation of the tibia to the femur;
information on a step length; and
information on characteristic landmarks ([0151]-[0154], Fig. 74, information on characteristic landmarks by identifying position of vertices of femur and tibia, and considers different poses of the knee, including the varus-valgus pose to identify specific cartilage loss).
Regarding Claim 38, Mahfouz and Lang teach the medical device system according to claim 22, and Mahfouz further teaches the system wherein the data processing unit is configured and programmed to compare the dynamic model data set with an experimentally obtained measurement data set to identify any matches and/or deviations ([0149]-[0155] the joint analyzed for implant placement includes the knee, [0132] where the evaluated bones around the knee are the femur and tibia information on characteristic landmarks by identifying position of vertices of femur and tibia, and considers different poses of the knee, including the varus-valgus pose to identify specific cartilage loss by comparing measured data to experimental data seen in cartilage loss), and to provide a user with relevant information at a notice unit ([0191] completed models of the patient may be output to a user interface to support an implant placement, thus the optimization from comparing the dynamic model data set with experimentally obtained measurement data for a joint experiencing cartilage loss will end with displayed optimized models at a notice unit / GUI).
Claim(s) 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mahfouz in view of Lang and further in view of Sessler (US 2017/0086671).
Regarding Claim 32, while Mahfouz and Lang teach the medical device system according to claim 22, and Mahfouz further teaches wherein the sensor elements comprise an acceleration sensor ([0120]) and wherein the data processing unit is configured and programmed to determine a range of motion of a bone based on a signal of the acceleration sensor ([0143], [0147] a range of motion of a joint, and correspondingly the bones attached to the joint, is measured as part of a kinematic stimulation) their combined efforts fail to teach the range of motion determination taking into account a time.
However Sessler teaches a joint kinematic analysis (Abstract) comprising the teaching that a range of motion of a knee joint can be characterized taking into account a time ([0056]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that the range of motion determination of Mahfouz specifically take into account a time as taught by Sessler as a way to standardize the particular way range of motion is characterized, ensuring consistency of the range of motion evaluation across applications of the invention.
Claim(s) 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mahfouz in view of Lang or, in the alternative, under 35 U.S.C. 103 as obvious over Mahfouz in view of Lang and further in view of Fanson et al (US 2021/0121237) (“Fanson”).
Regarding Claim 33, Mahfouz and Lang teach the medical device system according to claim 22, and Mahfouz further teaches the system comprising a notice unit on which notices for execution of characteristic movements by the patient can be output ([0188] tracking devices/sensors and displays can be used together, where a display is a notice unit for providing notices of information to users, and the specific language of “on which notices for execution of characteristic movements by the patient can be output” is read by Examiner as a necessary capability, but not a positive limitation), the data processing unit incorporating the information provided by the sensor unit in determining the relative position and/or of the relative mobility of the bones when movements are executed (See Claim 22 Rejection, kinematic analysis providing relative position and/or relative mobility of the bones is done in conjunction with sensor unit / tracking sensors. Examiner will also note that the “movements” referred to here are not explicitly tied to the “characteristic movements” tied to the notice unit).
Alternatively, should the claim language be read as positively incorporated, Fanson teaches a system for tracking anatomical structure with three dimensional models (Abstract) comprising a notice unit on which notices for execution of preset positions by the patient can be output, incorporating the information provided by sensor units in determining the positioning of bones ([0091]-[0092]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that the kinematic data evaluated in Mahfouz can be supported by guided instruction from a displayed overlay as taught by Fanson as a way to simplify the execution of predetermined movements and increase confidence in the final kinematic results of the joint and bones.
Claim(s) 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mahfouz in view of Lang and further in view of Aghazadeh (US 2014/0276864).
Regarding Claim 35, while Mahfouz and Lang teach the medical device system according to claim 22, and Mahfouz teaches wherein the data processing unit is configured and programmed to determine an axis of a bone ([0140] may be done as part of an implantation planning step), and Lang further teaches wherein the data processing unit is configured and programmed to determine axes of the bones based on information from the sensor elements and to relate one of the axes of the bones to the static model data set in such a way that the axes of the bones contained therein are superimposed with one of the axes determined based on the information of the sensor elements ([0358]-[0360] determination of a mechanical axis of the leg, i.e. a femoral or tibial axis, where motion data of a leg is tracked optically, [0211]-[0216] where motion data of a leg can also be found by sensor elements in a defined spatial relationship with the patient, [0751] an implant processing embodiment where a mechanical or anatomical axis of a bone associated with the knee is determined and the embodiment further relates the axes of the bone in such a way that axes of the bone contained therein are superimposed in a 3D model. From these teachings, one of ordinary skill in the art would understand that the optical position tracking to determine an axes of a bone can alternatively be found by another position tracking modality and understand that the superimposing of the determined axis on the 3D model of the bone amounts to the axes of the bones shown by the 3D is superimposed with the axes determined based on the information of the sensor elements), their combined efforts fail to teach wherein the data processing unit is configured and programmed to determine axes of the bones and an intersection of the axes based on information from the sensor elements and to relate the axes of the bones and the intersection of the axes to the static model data set in such a way that axes of the bones contained therein are superimposed with the axes determined based on the information of the sensor elements.
However Aghazadeh teaches a surgical implantation method relating to the knee (Abstract, Fig. 1, [0028]) comprising determine axes of the bones ([0097]-[0103]), a recognition that the intersection of the axes characterizes the user condition (Fig. 6, [0074]-[0075]), and the invention being related to surgeries addressing intersection-related abnormalities ([0014]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to determine axes of the bones of the tibia and femur and find the intersection of the axes as taught by Aghazadeh for the analyzed bones and joints of Mahfouz as this will characterize whether the patient is experiencing a varus or valgus deformity, which may in turn contextualize how a procedure of Mahfouz should proceed. Furthermore, it would be obvious to show the axes of both bones and their intersection as this will visually confirm the presence of the varus or valgus deformity for the healthcare provider.
Claim(s) 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mahfouz in view of Lang and further in view of Aghazadeh and further in view of Karade et al (US 2021/0007806) (“Karade”).
Regarding Claim 36, while Mahfouz, Lang, and Aghazadeh teach the medical device system according to claim 35, wherein, based on this, a pose of the axes of the bones, an intersection of the axes and a length of the bones are stored in the dynamic model data set (See Claim 35 Rejection¸ Aghazadeh: an intersection will be stored to characterize the presence of a varus or valgus deformity, Mahfouz: optimized pose data corresponding to a specific position of a static image is found and registered with the patient, indicating patient-specific data that would be stored in the dynamic model data set), their combined efforts fail to teach wherein a length of the bones are stored in the dynamic model data set.
However Karade teaches a three-dimensional modeling of a bone and identification of bone parameters (Abstract) comprising determining a length of the femoral and tibial bone ([0093]-[0094], [0165]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to additionally determine the length of the bone as a parameter in a dataset as taught by Karade as additional characterizing data of the bones taught in Mahfouz, Lang, and Aghazadeh as this identifies a degree of abnormality to correct (Karade: Abstract).
Conclusion
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/JAIRO H. PORTILLO/
Examiner
Art Unit 3791
/PUYA AGAHI/Primary Examiner, Art Unit 3791
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