DETAILED ACTION
Notices to Applicant
This communication is a non-final rejection. Claims 1-20, as filed 11/15/2023, are currently pending and have been considered below.
Foreign priority is generally acknowledged to GERMANY 10 2022 212 366.2 (11/18/2022).
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon and the rationale supporting the rejection would be the same under either status.
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.
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 elements in this application that use the word “means” (or “step for”) are presumed to invoke 35 U.S.C. 112(f) except as otherwise indicated in an Office action. Similarly, claim elements that do not use the word “means” (or “step for”) are presumed not to invoke 35 U.S.C. 112(f) except as otherwise indicated in an Office action.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
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”) in a claim creates a rebuttable presumption that the claim limitation is not 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 not 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 function without reciting sufficient structure, material or acts to entirely perform the recited 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.
The claim limitation “extension unit” has/have been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses/they use a generic placeholder “unit” coupled with functional language “for temporally extending the patient model” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier.
Since the claim limitation(s) invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, claim 12 has been interpreted to cover the corresponding structure described in the specification that achieves the claimed function, and equivalents thereof.
This feature is described in [0023] of the specification: “The extension unit may be one of a plurality of functional units implemented by hardware and/or software.” Thus, the term “extension unit” in claim 12 is interpreted as a computer executing logic to perform the transformation.
If applicant wishes to provide further 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 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 1-20 rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claims do fall within at least one of the four categories of patent eligible subject matter 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.
Step 1
The claim(s) recite(s) subject matter within a statutory category as a process, machine, and/or article of manufacture which recite:
1. A method for managing a virtual patient model of a patient for a series of treatment, examination procedures, or treatment and examination procedures occurring over time, the method comprising:
--describing, by the virtual patient model at least at a first time point at which the patient is described by first patient parameters, at least a surface of the patient at the first time point (abstract idea – mental process because a person can describe the surface of a patient at a time point mentally or with pen and paper; to the extent that this limitation is non-abstract, it merely applies the abstract idea with a computer); and
--extending the virtual patient model at least at a second later time point at which the patient is described by second patient parameters, using the first patient parameters and second patient parameters for describing at least the surface of the patient by at least one model transformation at the second time point (abstract idea – mental process and the mathematical concept of a model transformation relating patient parameters to a described surface).
Claim 1 is presented as an exemplary claim but the same analysis applies to the other claims 2-20.
Step 2A Prong One
The broadest reasonable interpretation of these steps includes mental process and mathematical concepts because the italicized portions are analogous to steps a human could perform mentally and amount to logic processes. For example, but for the “virtual” patient model language, describing at least a surface of a patient at a first time point and extending that description to a second later time point using the first and second patient parameters are analogous to an oncologist sketching a body outline of a patient at a first session and re-drawing the sketch at a later session using updated body metrics. The model transformation tying the patient parameters to the described surface is a mathematical concept.
Dependent claims further narrow or define the abstract idea. For example, claims 2 and 14 narrow the mathematical model; claims 9 and 10 recite mathematical concepts like principal component analysis; claims 3-5 and 15-17 recite steps that can be performed mentally like tracking locations and assigning dose information; claim 11 names the data being analyzed by the abstract ideas.
Step 2A Prong Two
This judicial exception is not integrated into a practical application. In particular, the additional elements do not integrate the abstract idea into a practical application, other than the abstract idea per se, because the additional elements:
amount to mere instructions to apply an exception. For example, the “virtual” patient model of claim 1-11, the patient model management facility of claim 12, and the non-transitory storage medium with instructions in claims 13-20 amount to invoking computers as a tool to perform the abstract idea, see applicant’s specification [0023], see MPEP 2106.05(f))
add insignificant extra-solution activity to the abstract idea. For example, generating a representation of the patient in claims 6-8 and 18-20 amounts to data outputting (to the extent that it is not fully abstract and performable in the human mind or with pen and paper, see MPEP 2106.05(g))
generally link the abstract idea to a particular technological environment or field of use such as medical treatment and examination procedures including radiation treatments, see MPEP 2106.05(h))
Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims. For example, claims 6-8 and 18-20 recite additional limitations which amount to invoking computers as a tool to perform the abstract idea. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation and do not impose a meaningful limit to integrate the abstract idea into a practical application.
Step 2B
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to discussion of integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply an exception, add insignificant extra-solution activity to the abstract idea, and generally link the abstract idea to a particular technological environment or field of use. Additionally, the additional limitations, other than the abstract idea per se amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields. For example, applying the at least one model transformation at each time point amounts to performing repetitive calculations, Flook, MPEP 2106.05(d)(II)(ii). Assigning and keeping the impact information amounts to electronic recordkeeping, Alice Corp., MPEP 2106.05(d)(II)(iii). The computer implementation is well-understood, routine, and conventional as described in the specification [0023]: “[t]he patient model management facility may include a computing facility, that may, for example, have at least one processor and at least one storage.”
Dependent claims recite additional subject matter which, as discussed above with respect to integration of the abstract idea into a practical application, amount to invoking computers as a tool to perform the abstract idea. Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Popescu (US-20190172570-A1) in view of Black (US-20100111370-A1).
Regarding claim 1, Popescu discloses: A method for managing a virtual patient model of a patient for a series of treatment, examination procedures, or treatment and examination procedures occurring over time (“the second patient model provided can improve diagnosis and/or therapy of the patient since the necessary items of information are provided in the same coordinate system and can therefore be evaluated in correlation,” [0092]; “a cumulative exposure parameter over a plurality of examinations and hence to provide better information for any possible follow-up examinations,” [0107]), the method comprising:
--describing, by the virtual patient model at least at a first time point at which the patient is described by first patient parameters, at least a surface of the patient at the first time point (“A patient model of a patient comprises one or more image datasets of the patient… a patient model can comprise further medical data relating to the patient (for example laboratory data, operation reports, diagnoses) or personal data (for example name, age, gender, height, weight). A patient model can be assigned a point in time,” [0152]; “an optical image dataset, in particular a three-dimensional optical image dataset,” [0166]); and
--extending the virtual patient model at least at a second later time point at which the patient is described by second patient parameters…by at least one model transformation at the second time point ([0152]; “The determination of a modified first image dataset enables the first image dataset to be adapted to the current anatomy of the patient based on the transformed second image dataset,” [0094]; “the result of growth processes in children and adolescents, a change in the body-mass index or changes due to muscle build-up, muscle atrophy and/or natural ageing processes,” [0179]).
Popescu does not expressly disclose but Black teaches: using the first patient parameters and second patient parameters for describing at least the surface of the patient (“The body is initialized in the known pose with shape parameters predicted from the input measurements (e.g. height, gender, age),” [0364]; “Anthropometric data such as height and weight specified by the user are obtained to find an estimated body shape,” [0143]; “If a person has multiple body scans obtained on different dates, they may all be maintained in the database,” [0380]).
It would have been obvious to a POSITA before the effective filing date to expand Popescu’s adaptation of the patient model to include the measurement-driven shape estimation of Black because this “simplifies the estimation problem and means that accurate measurements can be obtained even with noisy, limited or ambiguous sensor measurements” (Black [0021]).
Additionally, each element is taught by either Popescu or Black. Black’s shape estimation from measurements does not affect the normal functioning of the elements of the claim which are taught by Popescu. Because the elements do not affect the normal functioning of each other, the results of their combination would have been predictable. Therefore, before the effective filing date of the claimed invention, it would have been obvious to combine the teachings of Black with the teachings of Popescu since the result is merely a combination of old elements, and, since the elements do not affect the normal functioning of each other, the results of the combination would have been predictable.
Regarding claim 2, Popescu does not expressly disclose but Black teaches: wherein the patient model is at least partially a polygonal model with vertices and faces defined thereby, wherein the at least one model transformation changes a position of vertices based on the first patient parameters and the second patient parameters (“SCAPE is a deformable, triangulated mesh model of the human body that accounts for different body shapes, different poses, and non-rigid deformations due to articulation,” [0119]; “Since all model vertices are in correspondence, it is easy to measure the Euclidean distance between vertices of different models,” [0380]).
The motivation to combine is the same as in claim 1.
Regarding claim 3, Popescu discloses: wherein spatial features of the patient model described by location information at the first time point are tracked at the second time point (“the bone structures are first adapted to the changed anatomy,” [0180]; “items of information are provided in the same coordinate system and can therefore be evaluated in correlation,” [0092]).
Regarding claim 4, Popescu discloses: wherein for at least one time point, impact information related to the treatment, examination procedures, or treatment and examination procedures is assigned to the location information for creating a four-dimensional impact map based on the patient model (“assigns a maximum radiation dose to coordinates of the patient,” [0217]; “a spatial distribution of the exposure relative to the patient coordinate system PCS,” [0185]; “cumulative exposure parameter over a plurality of examinations,” [0107]).
Regarding claim 5, Popescu discloses: wherein for radiation treatment, radiation examinations, or radiation treatment and radiation examinations the impact information comprises dose information (“the radiation dose absorbed by the patient due to the recording of the second image dataset,” [0183]; “the radiation dose additionally absorbed as a result of the recording of the second image dataset MI.j is added to the first exposure parameter,” [0184]).
Regarding claim 6, Popescu discloses: characterized in that a representation of the patient is generated from the patient model for at least one of the time points covered thereby in which the impact information is reproduced true to location (“the method further comprises the method step of superimposing the second image dataset with the first image dataset via an output unit,” [0110]; “The spatially-resolved maximum radiation dose can also be interpreted as an image dataset relative to the patient coordinate system PCS,” [0217]).
Regarding claim 7, Popescu discloses: wherein the representation is of at least the patient's surface (“the registration image is a three-dimensional optical image of the patient,” [0099]; “a superimposed display enables the enables the second image dataset to be displayed in a larger anatomical context of the first image dataset,” [0110]).
Regarding claim 8, Popescu does not expressly disclose but Black teaches: wherein the impact information is provided by color coding (“This distance can be assigned a color from a range of colors that signify the type of change…Color can alternatively be mapped to other shape attributes (such as curvature) computed from the mesh. The colors are then used to texture map the body model for display on a graphical device,” [0380]).
The motivation to combine is the same as in claim 1.
Regarding claim 9, Popescu discloses: wherein the model transformation is ascertained statistically or by machine learning ([0178]-[0179]).
Regarding claim 10, Popescu further discloses statistical methods applied to patient models of other patients in [0179]. Popescu does not disclose but Black further teaches: wherein for the statistical ascertainment of the model transformation, three-dimensional scan datasets of a population to be ascertained, that are provided and describe at least the surface of a person for different time points and to which in each case the patient parameters for the respective time points are assigned, are subjected to principal component analysis for classes of comparable patient parameters and/or at least substantially the same patient parameters, and, to ascertain the model transformation, results of the principal component analysis are related to the assigned patient parameters (“A training set is constructed of body shape deformations between the template mesh and over 2000 body scans of North American adults with roughly equal gender representation…PCA” [0127]; “When ancillary data is stored, it is associated with the most current scan at that time,” [0380]; “men and women have different shapes and the optimal measurement predictions may use different shape coefficients or vertices. The same is true for different ethnic groups or age groups,” [0316]; [0127]; [0296]).
The motivation to combine is the same as in claim 1.
Regarding claim 11, Popescu discloses: characterized in that the first patient parameters and the second patient parameters comprise at least one of a patient's height, weight, age, or gender (“. Examples of such scalar parameters are the weight, height, age and gender of the patient,” [0168]).
Claims 12 and 13 are substantially similar to claim 1 and are rejected with the same reasoning. The Examiner further notes that Popescu discloses a non-transitory computer readable medium ([0074]-[0075]).
Claims 14-20 are substantially similar to claims 2-8 are rejected with the same reasoning.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Hoornaert (US-20090003527-A1) discloses “[e]ach patch is color coded to indicate the dose absorbed to the nearest interval” [0008].
Allen (Brett Allen, Brian Curless, and Zoran Popović. 2003. The space of human body shapes: reconstruction and parameterization from range scans. ACM Trans. Graph. 22, 3 (July 2003), 587–594. https://doi.org/10.1145/882262.882311) discloses “a form of feature analysis that enables modifying individuals by editing multiple correlated attributes (such as height and weight), plausible shape synthesis using only markers, and transfer of animation controls (skeletal and skinning) between the reconstructed models,” page 2.
Hoernig (US-20200281539-A1) discloses “Due to the improved precision of the digital twin, it is possible to refine the positioning of the patient and the setting of the system parameters. Due to the exact knowledge of the contours of the patient, the resolution requirements on any available cameras of the medical engineering examination apparatus can be reduced in order to recognize the final location of the patient on a patient couch,” [0072].
Nishi (JP5274526B2) discloses “An object of the present invention is to display the positional relationship between the skin dose information calculated in the treatment plan and the patient body surface with high accuracy on a patient model displayed on a display device visible in the treatment room,” page 2, and “it is possible to make a judgment with reference to the past skin dose value and the future skin dose value to be irradiated. Therefore, an appropriate treatment can be performed for each irradiation,” page 4.
Park (Park, Byoung-Keon & Reed, Matthew. (2015). Parametric body shape model of standing children aged 3–11 years. Ergonomics. 58. 1-12.) discloses “a linear regression analysis was conducted to predict principal component scores using stature, body mass index (body mass in kilograms divided by stature in meters squared), and the ratio of erect sitting height to stature (SHS) as predictors,” page 6; “A statistical body shape model (SBSM) for children was developed for generating a child body shape with desired anthropometric parameters,” page 1.
Johnson (Johnson PB, Borrego D, Balter S, Johnson K, Siragusa D, Bolch WE. Skin dose mapping for fluoroscopically guided interventions. Med Phys. 2011 Oct;38(10):5490-9.) teaches: “A color map consisting of a blue to red spectrum indicates the intensity of the irradiated area,” page 5495; “The output of the system is a visual indication of skin dose mapped onto an anthropomorphic model at a resolution of 5 mm,” page 5490.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA BLANCHETTE whose telephone number is (571)272-2299. The examiner can normally be reached on Monday - Thursday 7:30AM - 6:00PM, EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Shahid Merchant, can be reached on (571) 270-1360. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSHUA B BLANCHETTE/Primary Examiner, Art Unit 3624
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