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 .
Reason for Non-Final Action
The applicant’s amendment dated 06/17/2025 was not entered into the USPTO systems. Therefore the examiner’s previous Non-Final Action was inappropriately based on the applicant’s 05/13/2025 amendment. As such this action has been made non-final in order to properly address 06/17/2025 amendment.
Specification
The amendment filed 06/17/2025 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: The amendment attempts to enter new matter into the specification by deleting matter in a way that broadens the specification. More specifically, the [Volume with Anatomical Structure] vector was constrained to [0, 1] as per the originally filed specification with criteria for being a 0 or 1 set forth explicitly; however, the applicant’s amendment would broaden this to be [0, x] with criteria for being 0 but with criteria for being non-zero omitted and thus now open ended/not-constrained so as to have no descriptive limit as to how the values of non-zero terms should be determined nor what value (e.g. 0.125, a range of 0-3, a function f(x), or other independent variable, etc.) these terms should have.
Applicant is required to cancel the new matter in the reply to this Office Action.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-11 and 18-20, 23, and 25-26 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claims 1 and 18, the claims recite “generate a synthetic computed-tomography (CT) image of the patient by fitting detailed patient surface geometry of the surface image to a predicted internal anatomy generated from a collection of body scans, wherein the synthetic CT image comprises a plurality of voxels, and wherein each voxel of the plurality of voxels provides an estimate of expected material density for the patient”. However, the originally filed disclosure does not set forth how one would accomplish creating a synthetic CT of a patient with only a surface image and collected body scans (e.g. estimated density) where a surface image (which would have no information on organs and just surface information like clothing, skin, hair) and the estimated density/collection of scans (which appears from the specification just to be weighting volumes of organs that are unknown in the surface image) to show the interior tissues and organs of a body. The foregoing being true regardless of whether or not the surface image is fitted to a collection of body scans which will be addressed separately below.
The inventor’s specification supplies two examples of equations to denote how a surface image becomes a synthetic CT. CTsynth = Wskin * Vskin + Wiungs * Vlungs + wpelvis * Vpelvis + Wskull * Vskull ... (t); which is said to be weights and “V” which appears to be masks; where it is unclear what the Vskin, Vlungs, Vpelvis and Vskull are representing from either the surface image or the estimated density and how they would be found from a surface image. The second equation is A * [Body Surface Volume] = [Volume with Anatomical Structure]. However, there is no explanation on what type of regression A is and simply states that the matrix of the body surface volume would be 0s and 1s which would imply only two image possibilities. The only other insight is through a reference to US 9525582 which uses a surface image to create an avatar where the avatar is still a mesh and not representing internal organs or tissues of a human. Furthermore, the drawings only show the image of the synthetic CT and no image of the surface image. Applicant’s own figures even show the synthetic CT has spine, heart, liver, stomach and kidneys, lungs and other internal tissues. And the question is how does one go from a surface image of skin to an internal image of organs.
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Synthetic CT has a well-known definition in the art. The synthetic CT image providing an estimated measure of attenuation and providing a surface depth model of the patient could be found in a known synthetic CT. As these are not definitions just information provided within the synthetic image. As seen above, the synthetic CT of the originally filed disclosure does not appear to just show measure of attenuation or a surface depth model. Synthetic CT images are known to be made from MRI T1 and T2 images. When reviewing the specification, paragraph [0022] does point out a model also being used to help create this synthetic CT. However, further review does not give enough evidence or direction to understand how a model and surface image can be used to create a synthetic CT (or image of the interior of a subject based on intensity values, Hounsfield units that result in internal tissue). The specification rather just states the term “model” which is not enough information to show possession as this would be a specific algorithm or equations to achieve the outcome as claimed.
Applicant’s figures illustrate that the synthetic CT shows organ locations and internal tissue as seen in Fig. 5 reproduced below element 250.
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The following are examples of a CT without contrast and a synthetic CT show how they appear to be very similar in nature and do show internal tissue and representations of organs.
Example of CT without contrast of lungs in a sagittal view*
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* Bhalla AS, Das A, Naranje P, Irodi A, Raj V, Goyal A. Imaging protocols for CT chest: A recommendation. Indian J Radiol Imaging. 2019; 29(3):236-246. doi:10.4103/ijri.IJRI_34_19.
Example of synthetic CT from MRI* See below:
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* Siemens, “MR-only RT planning for the brain and pelvis with Synthetic CT”.
The specification also points to US Patent 9524582 as how a synthetic image is created using a model as well as a surface image. This Patent, however, is silent on getting estimated attenuation and a surface depth model. This patent takes a surface image to create a surface mesh to help plan a medical image. The patent uses a point cloud to then develop an avatar mesh (see Fig. 7 and Fig. 1); however, all the information appears to be developing information on a hollow (3D) mesh. The patent does not state how the model and surface image can be used to create a synthetic CT image that also provides an estimated measure of attenuation and provides a surface depth model. The article (Shu-Hui Hsu et al., “Investigation of a method for generating synthetic CT models from MRI scans of the head and neck for radiation therapy” 2013 Phys. Med. Biol. 58 8419) shows how complicated an algorithm and equations are to develop a synthetic CT even from MRI. See below reproduced figures and paragraphs from Shu-Hui Hsu et al.
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The detail for which is presented in the equations and explications on how an MR can be taken to CT illustrates how detailed information on creating a synthetic CT is presented and how detailed one would need to be in order to show possession at the time of filing.
Siemen’s own white paper illustrates the complexity for which Synthetic CT images are produced and complexity of the algorithm to even go from an MRI which shows internal tissue to synthetic CT.
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Because the originally filed disclosure is seen as broad, while the intent of the invention specific, the claims/application are not seen as adhering to the written description requirement. The question still remains on how one would go from a surface image to creating or generating a synthetic CT. There is not enough direction, skill in the art, nor predictability in the art for one to make or use the invention as it is unknown how a surface image can be used to create a synthetic CT image.
In closing, the specification appears to be lacking in description for the equations and explanations needed to create a synthetic CT in a way to show that the applicant possessed the claimed invention at the time of filing. No paragraphs in the specification state how this was accomplished. The specification [0022]-[0025] appear to be putting forth the reasoning that a surface image can be used to create a synthetic CT. However, no details in those paragraphs show how this is accomplished. The two equations are examples. Also, the equations state elements but do not define how the elements were created. For example, the regression matrix A is not described to be anything but a regression matrix; begging the question of what regression was used to accomplish said conversion. Also, it is unclear how the surface image volume would ever have a 1 value in it to represent internal tissue when all the image contains is information of outside surfaces and thus would only be a matrix of zeros. The other equations states that weights (which can be approximations of houndsfield units) can be a representation of brightness and can be added up after being multiplied with some type of vector. It is not described or explained how the V values were obtained in order to use them with the weighted values. There is not enough explanation in the specification to show that applicant had possession of the synthetic CT from the surface image of a camera at the time of filing.
Claims 2-11 and 19-21 and 23 are each similarly affected, at least by virtue of dependency.
Additionally, in the foregoing the examiner mentioned in the foregoing rejection that the use of “fitting detailed patient surface geometry of the surface image to a predicted internal anatomy generated from a collection of body scans,” would be addressed separately. To that end, the examiner notes that the term “fitting” is not present in the originally filed disclosure and “fit” only appears twice in the original specification, at [0022] and [0029] and where [0029] addresses deforming the already formed initial synthetic CT image based on later acquired PET data and thus could not be relevant to the process of creating the synthetic CT image. Likewise, “detailed patient surface geometry” only occurs once at [0022] and geometry of any kind only occurs at [0022]-[0023]. Given as much [0022]-[0023] would have to fully describe how this fitting is conducted to form a synthetic CT and, as already addressed above, the disclosure does not reasonably inform one of ordinary skill in the art how to form a synthetic CT in any way, much less by the claimed step of fitting.
However and to fully address all aspects of [0022], the examiner notes that the text of [0022] recites: “In some embodiments, the synthetic CT image 250 is generated by employing a model based approach to fit a depth image data of a person. The model based approach can include applying one or more learning algorithms including a statistical correlation model between the detailed patient surface geometry (from the surface image) and the anatomical structures (generated from a collection of real and/or synthetic body scans)”. As such, the applicant’s use of such fitting requires and is based on a model based approach using “one or more learning algorithms including a statistical correlation model”. This is the applicant’s only relevant disclosure and even then, the statement only provides the information that “a statistical correlation model” (a model which is itself undisclosed as there are no details as to what this model is or how it is formed) can be included in the learning algorithm (e.g. the algorithm can comprise, but clearly does not consist of this model, as correlation is generally not considered learning) without providing anything else for the reader to go on. This alone is not adequate written description to allow one of ordinary skill in the art to discern what sort of fitting / what sort of algorithm the applicant had to enact said fitting that the applicant had in their possession at the time of filing; and moreover, it certainly does not provide enough written description to allow one of ordinary skill in the art prior to the date of invention to make or use an invention commensurate with the scope of the claims. There are no other mentions of related terminology that addressed the claimed scope (e.g. “training” is not present, “trained” only occurs in [0031] and then only to describe the human reviewer, etc.) in the specification itself. Likewise, the examiner has already addressed the incorporated documents in the foregoing rejection since none of the incorporated documents adequately describe forming a synthetic CT image in the first place, but for the sake of thoroughness again notes that the incorporated documents do not disclose the claimed subject matter. For example, U.S. Pat. No. 9,524,582 is incorporated by the applicant and describes using learning to determine poses and model the deformation of the human body as a mesh. However, the document does not ever mention synthetic CT images nor does it even mention determine tissue density (much less Hounsfield units/attenuation maps) of the patient’s internal tissues. As such and for the foregoing reasons, neither the specification nor incorporated disclosure contains any adequate disclosure for the general case of forming a Synthetic CT image, and for the learning algorithms in particular it can be seen that “learning” is only mentioned twice in that document, once to describe the SCAPE method known in the prior art of pose determination and once to describe how joint landmarks for a mesh template could be positioned, neither of which relate to forming the synthetic CT nor address what sort of model and what algorithms the model would contain, much less how these would be utilized to form such synthetic CT images.
In closing, it can be seen that the first rejection clarifies that the “generation of a synthetic CT image of the patient" from a surface image and collection of body scans, regardless of any other factors as to how, is not adequately described in the specification. Similarly, the second rejection addresses how applying the use of fitting in the applicants disclosure is based on a statistical correlation model containing learning algorithm(s) but where neither the model nor the algorithm(s) are disclosed and therefore where the step of generating the synthetic computed-tomography (CT) image of the patient “by fitting detailed patient surface geometry of the surface image to a predicted internal anatomy” is separately and additionally not adequately described.
Claims 2-11, 19-20, 23, and 25-26 are each similarly affected by these two issues, at least by virtue of dependency.
Response to Arguments
Applicant’s arguments, see page 2, filed 06/17/2026, with respect to the interview/use of a prior claim set have been fully considered and are persuasive. The current action is therefore made Non-Final and the arguments of 06/17/2025 will therefore be additionally responded to below.
Applicant's arguments filed 06/17/2025 with respect to the 112(a) rejection have been fully considered but they are not persuasive as follows:
The applicant initially cites their legal position on page 9 which is acknowledged as relevant background but does not allege a specific defect in the rejection.
The applicant then opines on page 9-10 that regarding claims 1 and 18 the use of “a predertemined estimate of expected material density” is provided in [0022] of the specification and that this is generated by “matching the detailed patient surface geometry to a fixed 3D volume” such as a “fixed normalized value” which are provided in [0025]-[0026] and that these adequately describe the formation of the synthetic CT image. In this instance the examiner notes that none of the applicant’s chosen terminology is actually present in the specification (e.g. “predetermined” is not found in [0022], and none of the quoted terms are actually found in the specification). In this instance some similar language exists in each case, but that this is not a viable argument for multiple reasons. First and foremost it is spurious (e.g. the claim does not recite any of “a predertemined estimate of expected material density”, “matching the detailed patient surface geometry to a fixed 3D volume”, or a “fixed normalized value”). Secondly, each of [0022] and [0025]-[0026] and in particular [0022] has been addressed in detail above and in the foregoing actions and does not contain any adequate description of how to form the synthetic CT image by any means so the argument that language not in the claims and not matching, though similar to that of the specification, is enough to inform the reader how to do so involved a process as forming a synthetic CT image is prima facie not convincing. Third, even presuming that matching the surface geometry to a fixed 3D volume was adequately described, this does not by ordinary meaning result in the formation of a synthetic CT as that term would reasonably be understood such that the applicant’s conclusion would not follow from their premise even if, arguendo, it was accepted at face value. Fourth, the sections cited, e.g. [0022] rely on undisclosed algorithms (as addressed above) such that the argument also has serious logical and legal flaws as merely stating that the applicant possessed, but has not disclosed, the algorithm needed to form the synthetic CT does not by any reasonable standard meet the bar for overcoming a 112(a) rejection. Etc. As such and for these reasons and more the examiner is not convinced that 112(a) rejection should be overcome.
The applicant then continues by addressing what they describe as “non-limiting examples” on pages 10-11. In this instance the applicant then rehashes the subject matter of sections [0023]-[0026] which are fully addressed above and which likewise have multiple issues. As a non-starter these do not relate to the claims and are each spurious. The actual claim language under examination and rejected by the examiner is: “generate a synthetic computed-tomography (CT) image of the patient by fitting detailed patient surface geometry of the surface image to a predicted internal anatomy generated from a collection of body scans”. These sections speak to other unclaimed means, where the fitting is addressed in [0022] and relies upon undisclosed algorithms. Likewise, the examiner cannot help but note that none of these sections actually inform the reader how to form a synthetic CT in the first place. They at best inform the reader how to take a generic attenuation map and form a tailored attenuation map that is deformed according to/idealized from a surface image. This may well be useful and an improvement on more basic attenuation mapping methods, but it is not a synthetic CT as it contains no actual data from the internals of the patient. These both being noteworthy as they relate to the different rejections related to this claim language.
The applicant then continues on page 12 with the main thrust of the argument that the synthetic CT image includes “estimates” (bolded, properly, for emphasis) and therefore that the disclosure is adequate, further opining that later use of PET data (something unclaimed in claims 1 and 18) is used to refine this estimate. This should be broken down into its separate parts as one of these arguments gets to the heart of the issue. First and simply, the applicant’s arguments that the intent to later include PET data is spurious to the current claim drafting and would not be convincing even if later added into the claims as this does not lead to the formation of a synthetic CT as ordinarily understood and it is certainly the case that how the PET data (which does contain actual data from within the patient, but data that is fundamentally different in its mechanism of contrast from regulate CT despite both using x-rays) would be combined with this estimate for form a synthetic CT is not adequately disclosed. Secondly and much more importantly, the applicant is attempting to redefine what “synthetic CT” means in their arguments. This is an issue which the examiner brought directly to SPE Raymond, undersigned, because if the claim language relating to how the synthetic CT was formed redefined the term to be something other than that which would be ordinarily understood then the application would be close to allowability. However, after review it was determined that merely stating that the synthetic CT was “generated … by fitting detailed patient surface geometry of the surface image to a predicted internal anatomy generated from a collection of body scans” did not fundamentally re-define what the synthetic CT was. Redefining the term or otherwise removing the term and merely forming an attenuation map of expected values or the like is something that the examiner has urged the applicant to do in the past as it would overcome at least the first 112(a) issue raised above; however, this cannot be done via argument and the manner of claiming how the synthetic CT is generated falls substantively short of redefining what the synthetic CT image fundamentally is. Therefore this argument is not convincing to remove the 112(a) issues.
Applicant’s arguments, see pages 13-16, filed 06/17/2025, with respect to the 103(a) rejections have been fully considered and are persuasive. The associated rejections of the previous office action have been withdrawn.
The applicant then concludes on page 16 by opining that because all examined claims are allowable the remaining claims should be rejoined and allowed. In this instance the examiner was not convinced that examined claims are allowable due to the outstanding 112(a) issues and therefore is similarly not convinced that the application is due for a rejoinder at this juncture.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael S Kellogg whose telephone number is (571)270-7278. The examiner can normally be reached M-F 9am-1pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Raymond can be reached at (571)270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL S KELLOGG/ Examiner, Art Unit 3798
/KEITH RAYMOND/ Supervisory Patent Examiner, Art Unit 3798
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