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 .
Election/Restrictions
Applicant’s election without traverse of Group I, Claims 1-10, in the reply filed on 7/31/2026 is acknowledged.
Claims 11-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Groups II and III, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/31/2026.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “defining…an imaging characteristic in a radiation environment.” The claim does not define or further limit the scope of the term “radiation environment,” and the instant specification, while providing examples, does not strictly define the term. Therefore, the term “radiation environment” is indefinite as is it unclear what the scope of the intended use environment entails rendering the scope of the imaging characteristic unclear. For example, a radiation environment could comprise visible light, wherein the imaging characteristic includes color, or the radiation environment could comprise thermal radiation, wherein the imaging characteristic involves an infrared measurement for associating with a temperature. Claims 2-10 are indefinite based on their dependency. Additionally, claim 1 recites “deriving object model data,” but does not recite from what the object model data is derived from. That is, while the limitation is drawn to a step resulting in object model data for generating an object having amounts of first and second contrast agents that meet an imaging characteristic, this step does not appear to “derive” the object model data from any initial source/data, rendering the limitations indefinite.
Claim Interpretation
Claim 1 recites the term “radiation environment.” The claim does not define the term. The term is interpreted to include any environment experiencing any form of radiation, for example, electromagnetic radiation or thermal radiation.
Claim 1 recites the terms “first contrast agent” and “second contrast agent.” The claim does not define the terms. Therefore, any characteristic/property that may be considered to have differing contrast with respect to “imaging” may meet the claim terms.
Claim 1 recites the limitations “an amount of a first contrast agent and an amount of a second contrast agent.” The limitation does not limit “amount” to overall content, size, shape, weight, density, concentration, or any other measurement. Therefore, any value representing a quantity of the first and second contrast agents meets the limitation.
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 1-10 are rejected under 35 U.S.C. § 101 because the claimed invention is directed to judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because of the following reasons.
Step 2A, Prong 1: Is The Claim Directed to a Law of Nature, Natural Phenomenon, or an Abstract Idea?
[YES]: Claim 1 recites a step of defining an imaging characteristic and thus, comprises the metal step of selecting a parameter having only the minimal scope of being for an interior portion of an object to be generated by additive manufacturing and thus, comprises any visually-recognizable or machine-recognizable property related to an image of an object (e.g. color, density, size, shape etc.). Claim 1 also recites a step of deriving an object model data for generating the interior portion of the object by determining an amount of first and second contrast agents which comprises the mental step of calculating an amount of the first and second agents to obtain the defined characteristic. As the claims provide no boundaries as to the structure and/or complexity of the steps and data related to an object to be generated, and furthermore, do not recite the use of a computer, controller, or other means, the scope of the claim includes rudimentary calculations that may be performed in the mind. Therefore, these steps are drawn to a mental step of defining a characteristic/parameter and a mental step of calculating (mathematical equation) an object model having amounts of a first contrast agent and an amount of a second contrast agent to comprise the defined imaging characteristic and therefore are directed to abstract ideas.
Step 2A, Prong 2: Does the Claim Recite Additional Elements that Integrate the Judicial Exception Into a Practical Application?
[NO]: With respect Step 2A Prong Two, the examiner points out that the claim does not recite additional elements that integrate the judicial exception into a practical application. The claim derives/calculates “object model data” from an input data/characteristic and therefore, merely performs a mathematical calculation on data which does not integrate additional elements, steps, or structure and therefore, it does not appear that the claim “transform[s] the nature of the claim” into a patent-eligible application. See MPEP 2106.04 (II) (A) (2). Notably, Claim 1 does not actually manufacture the object in question, but merely generates object model data that could be used to manufacture an interior of an object.
Step 2B: Does the Claim Amount to Significantly More?
[NO]: With respect to Step 2B, when an additional element is considered individually by an examiner the additional element may be enough to qualify as “significantly more” if it meaningfully limits the judicial exception, and may also add a meaningful limitation by integrating the judicial exception into a practical application. Furthermore, limitations that the courts have found not to be enough to qualify as “significantly more” when recited in a claim with a judicial exception include adding the words “apply it” (or an equivalent) when the judicial exception, or mere instructions to implement an abstract idea on a computer, e.g., a limitation indicating that a particular function such as creating and maintaining electronic records is performed by a computer as discussed in Alice Corp., 573 U.S. at 225-26, 110 USPQ2d at 198. See also MPEP 2106.05(I)(A).
The limitations of claim 1 do not amount to significantly more. The additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea and is therefore not patent eligible.
Claims 2-10 are rejected as being dependent upon rejected Claim 1.
Claim Rejections - 35 USC § 102
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) 1, 3-4, 7, and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Geiger (WO 2016137425).
With respect to Claims 1 and 10, Geiger teaches a method of three-dimensional printing of a phantom for medical imaging, the method comprising first: defining a phantom object to be generated by 3D printing (i.e. additive manufacturing), the object having exterior and interior portions, and wherein the object has one or more selected characteristics for use in a radiation environment in which said characteristic(s) represent one or more relevant structures and/or calibration markers for imaging purposes. (para. 13, 19-20, 24). For example, the reference teaches “phantoms designed to test imaging characteristics, such as resolution, texture response, imaging artifacts, responsiveness to different settings, or other purposes may be designed” and in “another example, the phantom is designed and created for comparison with imaging results to verify the likely deformation or pathology for a particular patient (e.g., create more than one phantom with variations that may be possible for a patient, scan the phantoms, and identify the variation most similar to a patient based on scan response).” (para. 20).
Geiger teaches wherein the method further comprises deriving object model data for generating the phantom/object, and thus including the interior portion, by determining the relevant structure(s) needed to obtain the desired imaging characteristic. For instance, the reference teaches “[t]he feedback of the scan data or information derived from the scan data is then used to alter a print file defining the organ phantom or other phantom 18. The print file is altered in response to the scan data. The print file is as formatted for three-dimensional printing, for computer assisted design, or for a phantom design application.” (para. 53)(see also para. 52, 54-57). Geiger teaches wherein ” [t]he calibration may be improved by calibrating based on a phantom more closely representing the very anatomy to be imaged. Rather than relying on binary contrast in the phantom (e.g., two densities - one of the supporting material and the other of the artificial structure), any number of different densities may be provided by three-dimensional printing. A wide range of materials may be used for printing to obtain the desired densities, absorption or other characteristic depending on the imaging modality. The phantoms may be designed specifically for the type of imaging. For ultrasound phantoms, layer structures may be modeled in the phantom.” (para. 13).
Accordingly, Geiger is deemed to teach deriving object model data for generating the interior portion of an object by determining the amount of a first contrast agent (e. g. first material, density, absorption characteristic representing a first contrast agent) and the amount of a second contrast agent, relative to the first, to deposit such that the object generated according to the object model data comprises the defined imaging characteristic apparent in an image of at least part of the object comprising the interior portion captured in the radiation environment, wherein the first contrast agent and second contrast agent have different imaging characteristics in the radiation environment.
Geiger further teaches additively manufacturing one or more such phantom objects from the derived object model data. (para. 38-40). For example, Geiger teaches “[t]he three-dimensional printing provides a phantom with the selected characteristics. Different materials are deposited at different locations to form a three-dimensional objects with the characteristics distributed as designed. For example, the layers emulating the organ tissue structure are created. These layers may be different than the layers used for depositing by the three-dimensional printer.” (para. 40). “The different organ phantoms may have characteristics specific to the type of medical imaging. For example, ultrasound reflects from layers or transitions in density. The organ phantom may have different density layers typically of layers found in the organ. By defining the organ phantom with layers of anatomic structure, the organ phantom may more accurately emulate ultrasound imaging of the actual organ. As another example, MR is responsive to the types of molecules. The organ phantoms for MR imaging may have materials with certain molecules distributed throughout the organ phantom to emulate a typical distribution in the organ being represented. The selection may include selecting one or more characteristics of the organ phantom in addition to selecting a given organ phantom.” (para. 25-26).
In summary, Geiger is deemed to teach a method comprising each of the claimed steps and examples of methods for forming specific objects using said method sufficiently specific to anticipate the instant claim.
With respect to Claims 3-4, Geiger teaches wherein the imaging characteristic may be an absorption characteristic, including absorption of x-ray radiation and thus, teaches wherein the imaging characteristic is an attenuation (lesser absorption) of x-ray radiation, meeting claims 3 and 4.
With respect to Claim 7, Geiger teaches wherein the object is a medical imaging phantom. (see rejection of claim 1 above; abstract).
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) 2, 5, and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Geiger (WO 2016137425) as applied to claim 1 above.
With respect to Claim 2, Geiger teaches wherein the method comprises a plurality of contrast agents, and wherein the contrast agents may be drawn to different techniques for achieving the defined imaging characteristic, for example, differing materials or densities, and thus, encompass wherein one contrast agent has a “relatively larger change in the imaging characteristic.” (See rejection of claim 1 above). It would have been obvious to one of ordinary skill in the art to select first and second contrast agents having relatively larger/smaller change on the imaging characteristic, from the overlapping disclosure of Geiger, in order to obtain an object with desired imaging characteristics. See also MPEP 2144.
With respect to Claim 5, Geiger teaches wherein the plurality of contrast agents may be drawn to absorption/attenuation of a variety of imaging characteristics for a variety of imaging techniques, including x-ray, MRI, PET, and ultrasound. (para. 13-15, 21). It would have been obvious to one of ordinary skill in the art to select first and second contrast agents from two or more of the overlapping characteristics, including x-ray and magnetic resonance imaging (MRI), in order to enhance the utility of the object in a variety of imaging scenarios.
With respect to Claim 6, Geiger teaches wherein the method comprises a plurality of contrast agents for forming a plurality distinct regions/zones each having a distinct density (para. 13), including for example, plastic material with iodine for zones corresponding to blood regions, plastic without iodine for other zones. (para. 13, 38-39). Accordingly, it would have been obvious to one of ordinary skill in the art carrying out the method of Geiger, to comprise for an object having a plurality of regions/zones, defining an imaging characteristic for each zone of a plurality of zones within the interior portion, and wherein deriving object model data comprises determining an amount of the first contrast agent and amount of second contrast agent for each of the plurality of zones.
Claim(s) 8 is rejected under 35 U.S.C. 103 as being unpatentable over Geiger (WO 2016137425) as applied to claim 1 above, in view of O’Sullivan (US 2020/0354542).
With respect to Claim 8, Geiger teaches wherein the first and/or second contrast agent may comprise differing materials, including plastic, metal, ceramic, and/or other materials (see rejection of claim 1; para. 37); however, the reference does not specifically teach one of the recited agents of claim 8.
O’Sullivan teaches a method of additively manufacturing an object with one or more contrast agents for use in a medical imaging application, wherein the contrast agents may comprise metal, metal compound, inorganic compounds such as a metal oxide or metal salt, or organometallic, including wherein the metal may comprise gadolinium and wherein the agent may be in the form of a nanoparticle. (para. 1-2, 6, 17, 31-35, 40-41). The reference teaches that the method allows for forming objects having tailored radiopacity and/or regions of differing or graded radiopacity and that specific radiopacity may be used for defining a range of imaging characteristics. (para. 6, 29-30)
It would have been obvious to one of ordinary skill in the art to modify the method of Geiger to include a first and/or second contrast agent comprising one or more of gadolinium, a metal salt, a metallogenic compound, a metal oxide, and a metal nanoparticle, as taught by O’Sullivan, in order to enhance the control over the radiopacity of the additively manufactured object improving its utility in medical imaging applications.
Claim(s) 9 is rejected under 35 U.S.C. 103 as being unpatentable over Geiger (WO 2016137425) as applied to claim 1 above, in view of Miller (US 2010/0202001) and Kimblad (US 2018/0001381).
With respect to Claim 8, Geiger teaches wherein the method comprises deriving object model data for additive manufacturing, including any technique/device for additive manufacturing (see rejection of claim 1; para. 47); however, the reference does not specifically teach wherein deriving the object model data further comprises determining an amount of a fusing agent to deposit to cause coalescence (i.e. fusing/bonding) of a build material in additive manufacturing.
Miller teaches a method of making an object by additive manufacturing, in particular, a phantom for medical imaging, the method comprising deriving object model data for depositing a curable binder on a build material for additively manufacturing a solid object, and wherein the binder may comprise a contrast agent. (para. 6-10, 46-55). Miller is silent as to whether the step of curing includes absorption of energy.
Kimblad teaches a method of additive manufacturing (binder jet additive manufacturing) wherein successive layers of build material powder are deposited and selectively bound by depositing a binder that may be cured by absorbing energy (e.g. UV light) applied to the build material. (para. 1, 6-7, 42-45).
It would have been obvious to one of ordinary skill in the art to modify the method of Geiger to use an additive manufacturing method of forming a phantom for medical imaging comprising depositing a fusing agent to cause coalescence of a build material in additive manufacturing, as taught by Miller, in order to form an object with desired structure and imaging characteristics for use in medical imaging. It would further be obvious to one of ordinary skill in the art to modify the method of Geiger in view of Miller to select a binder that may be cured by absorbing energy applied to the build material, as taught by Kimblad, in order to obtain improved control over binder coalescence of build material, improving the granularity, quality, and/or consistency of the additive manufacturing method.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN A HEVEY whose telephone number is (571)270-0361. The examiner can normally be reached Monday-Friday 9:00-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Walker can be reached at 571-272-3458. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOHN A HEVEY/ Primary Examiner, Art Unit 1735
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