DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 101
2. 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.
3. Claim(s) 1-16, 18 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
An invention is patent-eligible if it claims a “new and useful process, machine, manufacture, or composition of matter.” 35 U.S.C. § 101. However, the Supreme Court has long interpreted 35 U.S.C. § 101 to include implicit exceptions: “laws of nature, natural phenomena, and abstract ideas” are not patentable. E.g., Alice Corp. v. CLS Banklnt'l, 573 U.S. 208, 216 (2014).
In determining whether a claim falls within an excluded category, we are guided by the Supreme Court’s two-step framework, described in Mayo and Alice. Id. at 217-18 (citing Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 75-77 (2012)). In accordance with the framework, we first determine what concept the claim is “directed to.” See Alice, 573 U.S. at 219 (“On their face, the claims before us are drawn to the concept of intermediated settlement, i.e., the use of a third party to mitigate settlement risk.”); see also Bilski v. Kappos, 561 U.S. 593, 611 (2010) (“Claims 1 and 4 in petitioners’ application explain the basic concept of hedging, or protecting against risk.”). For example, concepts determined to be abstract ideas, and thus patent ineligible, include certain methods of organizing human activity, such as fundamental economic practices {Alice, 573 U.S. at 219-20; Bilski, 561 U.S. at 611); mathematical formulas {Parker v. Flook, 437 U.S. 584, Appeal 2018-002948 Application 13/009,053 594-95 (1978)); and mental processes (Gottschalkv. Benson, 409 U.S. 63, 69 (1972)).
Specifically, claim(s) 1-16, 18 are directed toward at least one judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea), without significantly more. In accordance with the 2019 PEG, the rationale for this determination is explained below.
Step 1 Statutory Categories (streamlined analysis):
Establishing the broadest reasonable interpretation of the claim as a whole, does it fall under one of the four patentable categories of 35 U.S.C. § 101:
(1) process;
(2) machine;
(3) manufacture;
(4) composition of matter.
Step 1:
Representative claim 1 is directed toward a method, which is a statutory category of invention.
Representative claim 15 is directed toward an apparatus, which Is a statutory category of invention.
Representative claim 18 is directed toward an apparatus, which Is a statutory category of invention.
The claim(s) recite(s) the mental process for analyzing image data, accessing image data, and comparing a first image data and a second image data for accuracy, which is an “abstract idea,” without significantly more.
Revised Step 2A; Prong One of Two Prong Inquiry:
Although claim 1 recite a method/apparatus that falls within one of the four patentable categories of 35 U.S.C. § 101, the Supreme Court has "long held that this provision contains an important implicit exception" that "laws of nature, natural phenomena, and abstract ideas are not patentable." Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 70 (2012) (quotation omitted). To determine patentable subject matter a revised determination will be made using the 2019 PEG.
"First, we determine whether the claims at issue are directed to one of those patent-ineligible concepts" of "laws of nature, natural phenomena, and abstract ideas." Alice Corp. v. CLS Bank int'l, 134 S. Ct. 2347, 2355 (2014). "The inquiry often is whether the claims are directed to 'a specific means or method’ for improving technology or whether they are simply directed to an abstract end-result.". To determine if the claim “recites” and “abstract idea,” the Examiner identifies the specific limitations in the claim under examination the Examiner believes recites an “abstract idea” and determines whether the identified limitation(s) fall within at least one of the groupings of abstract ideas enumerated in the 2019 PEG.
The grouping of abstract ideas, as recited in the 2019 PEG, comprises:
(1) Mathematical Concepts/Formulas;
a. mathematical relationships;
b. a mathematical formula or equation;
c. a mathematical calculation;
d. formula;
(2) Mental Processes; and
a. concepts performed by the human mind or by pen and paper (e.g. observation, evaluation, judgement, opinion);
(3) Certain Methods of Organizing Human Activity (e.g. fundamental economic practice);
a. fundamental economic principles or practices (e.g. hedging, insurance, mitigating risk);
b. commercial or legal interactions (e.g. contracts, legal obligations, business relations, advertising;
c. managing personal behavior or relationships;
d. interactions between people (e.g. social activities, teaching);
Claim Analysis:
(a) Identifying the specific limitation(s) in the claim that recites an abstract idea (note: abstract idea is highlighted bold);
1. A computer-implemented method for identifying a region of interest for image registration, the method comprising:
analyzing three-dimensional CT or MRI image data of a tissue to identify one or more structural elements therein and determining a spatial arrangement of the structural elements;
accessing first ultrasound image data of the tissue and performing a first image registration of the first ultrasound image data with the CT or MRI image data at a first accuracy; and
identifying, based on the spatial arrangement of the structural elements, a region of interest for a subsequent second image registration of second ultrasound image data of the tissue with the CT or MRI image data at a second accuracy that is higher than the first accuracy.
(b) Determine whether the identified specific limitation(s) falls within at least one of the groupings of abstract ideas enumerated in 2019 PEG;
Claim Analysis:
The claim recites the limitation(s):
analyzing three-dimensional CT or MRI image data of a tissue to identify one or more structural elements therein and determining a spatial arrangement of the structural elements;
accessing first ultrasound image data of the tissue and performing a first image registration of the first ultrasound image data with the CT or MRI image data at a first accuracy; and
identifying, based on the spatial arrangement of the structural elements, a region of interest for a subsequent second image registration of second ultrasound image data of the tissue with the CT or MRI image data at a second accuracy that is higher than the first accuracy.
Thus, the limitation, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting “computer/processing” nothing in the claim element precludes the step from practically being performed in the mind. For example, but for the “computer (claim 1)/processing unit (claim 15)” language, the claim encompasses the user manually processing information. The mere nominal recitation of a generic computer / processing does not take the claim limitation out of the mental processes grouping. Thus, the claim recites a mental process.
The Examiner identifies that the Applicant’s claim limitations full under 2019 PEG group(s) of abstract idea is/are: (2) Mental Processes; (3) Certain Methods of Organizing Human Activity;
Because the claims are directed to the mental process for executing a contract, which is an abstract idea. Since the identified limitations(s) fall within any of the groupings of abstract ides enumerated in the 2019 PEG, the analysis should proceed to Revised Step 2A, Prong Two.
We must now examine the elements of the claim to determine whether it contains an “inventive concept’ sufficient to “transform” the claimed abstract idea into a patent eligible application. A claim that recites an “abstract idea” must include “additional features” to ensure the claim is more than a drafting effort designed to monopolize the “abstract idea.”
Revised Step 2A, Prong Two of Two Prong Inquiry:
The Examiner then makes a determination if there are there any additional element(s) or a combination of elements that apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that it is more than a drafting effort designed to monopolize the exception. Therefore, the additional element(s) or a combination of elements, recited in the claim, is beyond the judicial exception(s), and
Does the claim recite additional elements that integrate the judicial exception into a “practical application” of the exception? Requires an additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the exception.
Because the Examiner has found that the claims are directed to abstract ideas/judicial exception, the claims must include an “inventive concept” in order to be patent-eligible, i.e., there must be an element or combination of elements that is sufficient to ensure that the claim in practice amounts to significantly more than the abstract idea itself.
The relevant question is whether the claims here do more than simply instruct the practitioner to implement the abstract idea...on a generic computer.
Claim Analysis:
(a) Identifying the specific limitation(s) in the claim that recites additional element(s) or a combination of elements:
A computer-implemented method for identifying a region of interest for image registration, the method comprising:
analyzing three-dimensional CT or MRI image data of a tissue to identify one or more structural elements therein and determining a spatial arrangement of the structural elements;
accessing first ultrasound image data of the tissue and performing a first image registration of the first ultrasound image data with the CT or MRI image data at a first accuracy; and
identifying, based on the spatial arrangement of the structural elements, a region of interest for a subsequent second image registration of second ultrasound image data of the tissue with the CT or MRI image data at a second accuracy that is higher than the first accuracy.
(b) Does the claim as a whole integrates the mental process into a practical application?
Examples of limitations that are indicative of integration into a practical application:
Improvements to the functioning of a computer, or to any other technology or technical field, as discussed in MPEP 2106.05(a);
Applying or using a judicial exception to effect a particular treatment or prophylaxis for disease or medical condition;
Applying the judicial exception with, or by use of, a particular machine, as discussed in MPEP 2106.05(b); Effecting a transformation or reduction of a particular article to a different state or thing, as discussed in MPEP 2106.05(c); and Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception;
The Examiner considers whether the claimed invention pertains to an improvement in:
(1) The functioning of the computer itself; or
(2) Any other technology or technical field.
This is also referred to as a technological solution to a technological problem.
Determine, by the Examiner, that there is a technical explanation as to how to implement the invention in the Specification and the claim itself reflects the
improvement in technology. In determining to identify the “improvement” the Examiner searches both:
(1) The Specification; and
(2) The Claims;
The Specification must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as pertaining to an improvement in technology. For example, the Specification could identify a technical problem and explain how the Specification provides a technical solution.
As to the claims, after the Examiner has consulted the Specification and determined the disclosed invention pertains to an improvement in technology, the claim must be evaluated to ensure the claim itself reflects the improvement in technology. It must be determined whether the claim covers a particular solution to a problem or a particular way to achieve a desired outcome, as opposed to merely claiming the idea of a solution or outcome.
Under a “particular machine” consideration, a claim limitation can integrate a judicial exception by implementing a judicial exception with, or using a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim. This consideration is discussed in MPEP 2106.05(b).
A claim to add a generic computer or generic computer components and asserts that the claim integrates a judicial exception because the generic computer is 'specially programmed, or is a ‘particular machine, the Examiner should look at whether the added elements integrate the judicial exception. Merely adding a generic computer, generic computer components, or a programmed computer to perform generic computer functions does not automatically overcome an eligibility rejection.
Under a “particular transformation’ consideration, a claim limitation can integrate a judicial exception by effecting a transformation or reduction of a particular article to a different state or thing. This consideration is discussed in MPEP 2106.05(c).
Under “other meaningful limitations” consideration, a claim limitation can integrate a judicial exception by applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. This consideration is discussed in MPEP 2106.05(e).
Examples of limitations that are “NOT” indicative of integration into a practical application:
Adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea, as discussed in MPEP 2106.05(f);
Generally linking the use of the judicial exception to a particular technological environment or field of use, as discussed in MPEP 2106.05(h).
Result of Claim Analysis:
The claim recites the additional element(s): a computer (claim 1)/processing, the “processing unit” (claim 15) in the step(s) is recited at a high level of generality, i.e., as a generic processor performing a generic computer function of processing data. This generic processor limitation is no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. Therefore, the claim is directed to the abstract idea.
Thus, the exception is not integrated into a “practical application,” then the claim is “directed to” the exception, proceed to Step 2B.
Analysis Step 2B:
Because we determine the claims are directed to an abstract idea, we analyze the claims under step 2B of Alice to determine if there are additional limitations that individually, or as an ordered combination, ensure the claims amount to "significantly more" than the abstract idea. Alice, 134 S. Ct. at 2355 (citing Mayo, 566 U.S. at 76- 77)). Does the claim provide an inventive concept i.e., does the claim recite additional element(s) or a combination of elements that amount to significantly more than the judicial exception (e.g. abstract idea) in the claim?
Because the Examiner has found that the claims are directed to abstract ideas/judicial exception, the claims must include an “inventive concept” in order to be patent-eligible, i.e., there must be an element or combination of elements that is sufficient to ensure that the claim in practice amounts to significantly more than the abstract idea itself.
The relevant question is whether the claims here do more than simply instruct the practitioner to implement the abstract idea...on a generic computer.
Step 2B includes evaluation of the same considerations as revised Step 2A Prong Two, plus two additional considerations:
whether the additional elements amount to significantly more than the exception itself;
Claim Analysis:
A computer-implemented method for identifying a region of interest for image registration, the method comprising:
analyzing three-dimensional CT or MRI image data of a tissue to identify one or more structural elements therein and determining a spatial arrangement of the structural elements;
accessing first ultrasound image data of the tissue and performing a first image registration of the first ultrasound image data with the CT or MRI image data at a first accuracy; and
identifying, based on the spatial arrangement of the structural elements, a region of interest for a subsequent second image registration of second ultrasound image data of the tissue with the CT or MRI image data at a second accuracy that is higher than the first accuracy.
Claim Analysis Result:
Thus, taken alone, the additional elements do not amount to significantly more than the above identified judicial exception (the “abstract idea”). Looking at the limitations as an ordered combination, as a whole, adds nothing that is not already present when looking at the elements individually. There is no indication that the combination of elements, the ordered combination of the elements as a whole, improves the functioning of a computer or improves any other technology.
The additional elements of claim(s) 1 do not change the analysis as claim(s) 1 do not include additional elements that are sufficient to amount to significantly more than the judicial exception because alone, the elements do not amount to significantly more than the abstract idea. The additional elements of claim(s) 1 taken together, as an ordered combination, as a whole, also do not amount to significantly more than the abstract idea. The additional elements of claim(s) 1 include:
A computer-implemented method for identifying a region of interest for image registration,
Applicants “additional elements” disclose generic computer components performing generic computer functions which alone, do not amount to significantly more than the judicial exception. Within claim(s) 1/15, they are recited at a high level of generality and are functioning and processing instructions in a conventional manner known in the industry. Courts have held computer-implemented processes not to be significantly more than an “abstract idea” (and thus ineligible) where the claim as a whole amount to nothing more than generic computer functions merely used to implement an “abstract idea,” such as an idea that could be done by human analog (i.e. by hand or by merely thinking). This is the central issue with the claimed invention as the computer elements are merely used as a tool to carry out the “abstract idea,” to perform functions, such as:
analyzing three-dimensional CT or MRI image data of a tissue to identify one or more structural elements therein and determining a spatial arrangement of the structural elements;
accessing first ultrasound image data of the tissue and performing a first image registration of the first ultrasound image data with the CT or MRI image data at a first accuracy; and
identifying, based on the spatial arrangement of the structural elements, a region of interest for a subsequent second image registration of second ultrasound image data of the tissue with the CT or MRI image data at a second accuracy that is higher than the first accuracy.
which are well-understood and conventional to the industry. Thus, being taken alone, the additional elements do not amount to significantly more than the above identified judicial exception (the “abstract idea”). Looking at the limitations as an ordered combination, as a whole, adds nothing that is not already present when looking at the elements individually. There is no indication that the combination of elements, the ordered combination of the elements as a whole, improves the functioning of a computer or improves any other technology.
Their collective functions merely provide conventional computer implementation as the Specification, which merely indicate generic and conventional computing components, used as a tool to implement the “abstract idea, without specifically identifying improvements to the technology utilized, rather indicating technology is merely utilized as a tool to implement the “abstract idea.”
Applicant's limitations are represent instructions for the “abstract idea” and/or insignificant post-solution activity. Moreover, these limitations do not constitute significantly more because they are simply an attempt to limit the “abstract idea” to a particular technological environment. Viewing these limitations in combination with the elements that set forth the “abstract idea,” the claim(s) 1 merely instruct the process of
analyzing three-dimensional CT or MRI image data of a tissue to identify one or more structural elements therein and determining a spatial arrangement of the structural elements;
accessing first ultrasound image data of the tissue and performing a first image registration of the first ultrasound image data with the CT or MRI image data at a first accuracy; and
identifying, based on the spatial arrangement of the structural elements, a region of interest for a subsequent second image registration of second ultrasound image data of the tissue with the CT or MRI image data at a second accuracy that is higher than the first accuracy.
which are instructions to implement the “abstract idea.”
Furthermore, the limitations whish set forth the “abstract idea” do not appear to be sufficiently supported by the required algorithm(s) necessary to carry out their claimed function in a specific, limiting manner, thereby indicating a high level or preemption.
Conclusion
Thus, when all of the limitations of the claims are considered, both individually and as an ordered combination as outlined above, the Examiner concludes that the claim is not directed to a patent-eligible subject matter under 35 USC 101 because it does not amount to significantly more than the “abstract idea.”
Additionally, the Examiner would additionally point out the following:
“The method claims do not, for example, purport to improve the functioning of the computer itself. See ibid. (“There is no specific or limiting recitation of ... improved computer technology …”); Brief for United States as Amicus Curiae 28-30. Nor do they effect an improvement in any other technology or technical field. See, e.g., Diehr, 450 U. S., at 177-178. Instead, the claims at issue amount to “nothing significantly more” than an instruction to apply the abstract idea of intermediated settlement using some unspecified, generic computer.”
Also, the Examiner would like to point out that “claims for which computers are invoked merely as a tool...use of a computer as a tool — economic task, or method of conducting business, the computer acts as a device to move and hold data, but the computer is used merely in its ordinary capacity of routine computerization of bookkeeping functions are not tied to a technological advance.” “Furthermore, merely combining several abstract ideas does not render the combination any less abstract. RecogniCorp, 855 F.3d at 1327 (“Adding one abstract idea (math) to another abstract idea ... does not render the claim non-abstract.”); see also FairWarning IP, LLC v. latric Sys., Inc., 839 F.3d 1089, 1093—94 (Fed. Cir. 2016) (determining the pending claims were directed to a combination of abstract ideas).”
Also, the Examiner would like to point out that “an inventive concept that transforms the “abstract idea”’ into a patent-eligible invention must be significantly more than the “abstract idea” itself, and cannot simply be an instruction to implement or apply the “abstract idea” on a computer.”
Accordingly, there are no meaningful limitations in the claims that transform the judicial exception into a patent eligible application such that the claims amount to significantly more than the judicial exception itself.
Dependent claim(s) 2-14 when analyzed as a whole are held to be patent ineligible under 35 USC 101 because the additional recited limitations only refine the abstract idea further.
For instance, in claim(s) 2-14 the steps, under the broadest reasonable interpretation, are further refinements of [organizing human activities, mental process, mathematical concepts/formulas] because these steps further describe the intermediary steps of the underlying process.
In all the dependent claim(s), the judicial exception is not integrated into a practical application because the limitations are recited at a high-level of generality such that it amounts to no more than mere instructions to apply the exception using generic computer components. This is because the claim(s) do not affect an improvement to another technology or technical field; the claims do not amount to an improvement to the functioning of a computer system itself; the claims do not affect a transformation or reduction of a particular article to a different state or thing; and the claims do not move beyond a general link of the use of an abstract idea to a particular technological environment. In addition, the dependent claim(s) do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The additional elements of the instant underlying process, when taken in combination, together do not offer substantially more than the sum of the functions of the elements when each is taken alone. Thus, the claims as a whole, do not amount to significantly more than the
abstract idea itself. For these reasons, the dependent claim(s) also are not patent eligible.
Claim(s) 15 and 18 contains similar language or like deficiencies found in claim 1.
Dependent claim(s) 2-14, 16 do not add any limitations that would remedy the deficiencies outlined above and are rejected accordingly.
Claim Rejections - 35 USC § 112
4. 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.
5. Claims 1 and 15 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. Claims 1 and 15 are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as based on a disclosure which is not enabling. The disclosure does not enable one of ordinary skill in the art to practice the invention without "a memory, coupled to the processor, storing executable instructions, which is/are critical or essential to the practice of the invention but not included in
the claim(s). See In re Mayhew, 527 F.2d 1229, 188 USPQ 356 (CCPA 1976).
Claim Rejections - 35 USC § 102
6. 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.
7. 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.
8. Claims 1-5, 9, 11-16, 18 are rejected under 35 U.S.C. 102(a)(1)as being anticipated by Claus U.S. Patent Application No. US 2012/0093383 hereinafter (Claus).
Regarding claim 1, Claus discloses a computer-implemented method for identifying a region of interest for image registration (Image data may be processed and analyzed to identify regions of interest; paragraph 17, Figure 1), the method comprising:
analyzing three-dimensional CT or MRI image data of a tissue to identify one or more structural elements therein and determining a spatial arrangement of the structural elements (Based upon the analysis, target regions are selected as regions designated for imaging by subsequent imaging of the target region 22 selected may provide for greater spatial resolution; paragraphs 18, 23, 44 and also, paragraphs 52-53, 58 indicating that controlling a position, direction or orientation, ultrasound transducer power level settings, scan duration, MRI pulse sequences, projection angles, spatial relationship, and so on);
accessing first ultrasound image data of the tissue (Attributes or regions identified in the first image 20 or image data 14; paragraph 23) and performing a first image registration of the first ultrasound image data with the CT or MRI image data at a first accuracy (Derived based upon a first image 20 or image data 14 provide suitable information such that the subsequently generated images 33 can be optimally generated; at least paragraphs 23, 25, 51-53); and
identifying, based on the spatial arrangement of the structural elements, a region of interest for a subsequent second image registration of second ultrasound image data of the tissue with the CT or MRI image data at a second accuracy that is higher than the first accuracy (to identify regions of interest, ultrasound image data acquired in the second image of the regions of interest can be used to supplement CAD output obtained. Further, information or imaging data from tomosynthesis or CT and ultrasound may be used to further improve image quality; paragraphs 45, 47 and paragraphs 52, 58 illustrating scan parameters corresponding to the region of interest in the input image are generated and applied to obtain subsequent image data. The scanning parameters include information about the location of the region of interest (ROI) relative to the spatial relationship).
Regarding claim 2, Claus discloses the method according to claim 1, wherein identifying the region of interest based on the spatial arrangement of the structural elements comprises determining the number and/or density of the structural elements of different areas in the CT or MRI image data and/or determining areas in the CT or MRI image data that do not have any structural elements (Deriving may include localization and/or identification of other anatomical structures of diagnostic or contextual interest. These may include structural markers, such as BB's or other objects placed on or in the patient to identify a location where more thorough scanning is desired; paragraph 19).
Regarding claim 3, Claus discloses the method according to claim 1, wherein identifying the region of interest based on the spatial arrangement of the structural elements is performed taking into account boundary conditions as to the region of interest (Subsequent imaging of the target region 22 selected at step 18 may provide for greater spatial resolution (e.g. zoom-in) of a potential lesion. In one embodiment, projections of the target region at additional view angles are acquired, e.g., in order to achieve improved 3D characterization of the lesion located in the target region, when reconstructed using image data from the initial view angles and the additional view angles; at least paragraphs 17-19).
Regarding claim 4, Claus discloses the method according to claim 1, wherein performing the first image registration comprises aligning at least some of the structural elements identified in the CT or MRI image data with corresponding structural elements in the first ultrasound image data, and/or wherein performing the second image registration comprises aligning at least some of the structural elements identified in the CT or MRI image data in the region of interest with corresponding structural elements in the second ultrasound image data (Image processing circuitry 104 may register the ultrasound or tomosynthesis images such that respective regions in each image that correspond to one another are aligned. In this manner, a region identified in an image of one modality may be properly identified in images generated; paragraph 47).
Regarding claim 5, Claus discloses the method according to claim 1, wherein identifying one or more structural elements comprises determining high order image derivatives in the CT or MRI image data and determining, based thereon, the presence and approximate shape and/or orientation of the one or more structural elements (subsequent imaging of the target region 22 selected at step 18 may provide for greater spatial resolution (e.g. zoom-in) of a potential lesion, wherein projections of the target region at additional view angles are acquired, e.g., in order to achieve improved 3D characterization of the lesion located in the target region, when reconstructed using image data from the initial view angles and the additional view angles; paragraphs 17- 19).
Regarding claim 9, Claus discloses the method according to claim 1,wherein the first ultrasound image data and the second ultrasound image data is three-dimensional ultrasound image data and wherein identifying the region of interest comprises identifying only areas wherein at least one of the structural elements is present as being part of the region of interest and/or wherein the second ultrasound image data provides more detail in the region of interest than the first image data, and/or wherein the second ultrasound image data is non-uniform, providing more detail in the region of interest than in other regions (In tomosynthesis mammogram imaging, initial images 20 are acquired in three-dimensions so that, for example, the skin-line of the imaged breast may be found. Once the skin line is obtained, relevant scan parameters 26 may be extracted from the tomosynthesis image data so that subsequent images acquired, for example, by an ultrasound modality may focus only on the region bounded by the skin-line, thereby minimizing the ultrasound scan time and the overall imaging procedure time; paragraphs 19, 21-25).
Regarding claim 11, Claus discloses the method according to claim 1, further comprising performing the second image registration of the second ultrasound image data with the CT or MRI image data at the second accuracy (Registration is performed to register the input image to the reference image such that respective regions of interest in each image that correspond to one another are aligned; paragraphs 51-53).
Regarding claim 12, Claus discloses the method according to claim 1, wherein the first ultrasound image data is ultrasound image data obtained at a later time than the CT or MRI image data and/or wherein the second ultrasound image data comprises at least part of the first ultrasound image data and/or wherein the second ultrasound image data is ultrasound image data obtained after identifying the region of interest and/or wherein the second ultrasound image data is ultrasound image data obtained before identifying the region of interest (Ultrasound transducer power level settings, scan duration, MRI pulse sequences, projection angles and so forth. Wherein, parameter settings may be selected manually by a user according to the identified anatomy and/or other operational needs; paragraph 17).
Regarding claim 13, Claus discloses the method according to claim 1, wherein the second image registration is used for real-time adjustment of posture of an ultrasound transducer with respect to the tissue (skin line is obtained, relevant scan parameters 26 may be extracted from the tomosynthesis image data so that subsequent images acquired, for example, by an ultrasound modality may focus only on the region bounded by the skin-line, thereby minimizing the ultrasound scan time and the overall imaging procedure time; paragraph 19).
Regarding claim 14, Claus discloses the method according to claim 1, further comprising obtaining CT or MRI image data of the tissue (6) using a CT or MRI scanner and/or obtaining the first ultrasound image data and/or the second ultrasound image data using a two-dimensional or a three- dimensional ultrasound transducer (Combining the information from the two or more projection images, the 3D locations of suspected lesions can be identified, and additional projections of these regions can be acquired such as to increase the confidence in the CAD result, or in order to gain more information to characterize the lesion, or to perform a high-resolution reconstruction of the region containing the suspected lesion; paragraph 19).
Regarding claim 15, Claus discloses a system for identifying a region of interest for image registration (Image data may be processed and analyzed to identify regions of interest; paragraph 17, Figure 1), the system comprising:
a processing unit (Controller 54, Figure 2) operable to:
analyze three-dimensional CT or MRI image data of a tissue to identify one or more structural elements therein and determining a spatial arrangement of the structural elements (Based upon the analysis, target regions are selected as regions designated for imaging by subsequent imaging of the target region 22 selected may provide for greater spatial resolution; paragraphs 18, 23, 44 and also, paragraphs 52-53, 58 indicating that controlling a position, direction or orientation, ultrasound transducer power level settings, scan duration, MRI pulse sequences, projection angles, spatial relationship, and so on);
access first ultrasound image data of the tissue (Attributes or regions identified in the first image 20 or image data 14; paragraph 23) and performing a first image registration of the first ultrasound image data with the CT or MRI image data at a first accuracy (Derived based upon a first image 20 or image data 14 provide suitable information such that the subsequently generated images 33 can be optimally generated; at least paragraphs 23, 25, 51-53): and
identify, based on the spatial arrangement of the structural elements, a region of interest for a subsequent second image registration of second ultrasound image data of the tissue with the CT or MRI image data at a second accuracy that is higher than the first accuracy (to identify regions of interest, ultrasound image data acquired in the second image of the regions of interest can be used to supplement CAD output obtained. Further, information or imaging data from tomosynthesis or CT and ultrasound may be used to further improve image quality; paragraphs 45, 47 and paragraphs 52, 58 illustrating scan parameters corresponding to the region of interest in the input image are generated and applied to obtain subsequent image data. The scanning parameters include information about the location of the region of interest (ROI) relative to the spatial relationship).
Regarding claim 16, Claus discloses 16. the system according to claim 15, further comprising a CT or MRI scanner configured to obtain the CT or MRI image data and/or an ultrasound transducer configured to obtain the first ultrasound image data and/or the second ultrasound image data (In a CT system, the image data acquisition is typically initiated by an operator interfacing with the system via the operator workstation 70. Readout electronics detect signals generated by virtue of the impact radiation on the scanner detector, and the system processes these signals to produce useful image data; paragraphs 15, 17, 21, 42, 45, Figure 2).
Claim 18 is directed to a non-transitory computer-readable storage medium, and recite identical features as claim 1. Thus, claim 18 is rejected for the same reasons discussed in claim 1 above.
Claim Rejections - 35 USC § 103
9. 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.
10. Claims 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Claus in view of Hyun et al. U.S. Patent Application No. US 2011/0028844 (hereinafter Hyun).
Regarding claim 6, Claus does not explicitly disclose the method according to claim 1, wherein identifying the structural elements comprises obtaining Eigenvalues of a Hessian matrix applied to the CT or MRI image data and, based on the Eigenvalues, identifying the structural elements.
However, Hyun working in the same field teaches wherein identifying the structural elements comprises obtaining Eigenvalues of a Hessian matrix applied to the CT or MRI image data and, based on the Eigenvalues, identifying the structural elements (Denoting eigenvalues of the Hessian matrix; paragraph 30, Figure 4).
In view of the above, it would have been obvious to one having ordinary skill in the art at the time of the invention was made to combine the system of Claus as taught by Hyun to include: wherein identifying the structural elements comprises obtaining Eigenvalues of a Hessian matrix applied to the CT or MRI image data and, based on the Eigenvalues, identifying the structural elements. By doing so, the combined system of Hyun would have generated an image registration between a CT image and an ultrasound image has been introduced to compensate for inherent deficiencies of the ultrasound image (paragraph 003 of Hyun).
Regarding claim 7, Claus discloses the method according to claim 6.
However, Hyun teaches wherein identifying the structural elements comprises categorizing each of the Eigenvalues as low or as high positive or as high negative and determining that a structural element is present when a predetermined combination of categories of the Eigenvalues is determined (Diaphragm extraction section 141 may be operable to perform a Hessian matrix based flatness test upon the respective 3-dimensional ultrasound and CT images to extract the diaphragm; paragraphs 28-30, Figure 4).
Regarding claim 8, Claus discloses the method according to claim 1,
However, Hyun teaches wherein the first ultrasound image data and the second ultrasound image data is three-dimensional ultrasound image data, wherein the first ultrasound image data comprises a first subset of voxels of ultrasound image data of the tissue and wherein the second ultrasound image data comprises a second subset of voxels of ultrasound image data of the tissue, the second subset of voxels having a higher voxel-density in the region of interest than the first subset of voxels (From the respective 3-D ultrasound and CT images of the target object by selecting a largest surface among candidates surfaces that are obtained from voxels; a vessel extraction section configured to extract a vessel from the respective 3-D ultrasound and CT images of the target object by selecting vessel candidates by removing voxels with a higher intensity value than a reference boundary value; paragraphs 28-37, Figures 3-4).
In view of the above, it would have been obvious to one having ordinary skill in the art at the time of the invention was made to combine the system of Claus as taught by Hyun to include: wherein the first ultrasound image data and the second ultrasound image data is three-dimensional ultrasound image data, wherein the first ultrasound image data comprises a first subset of voxels of ultrasound image data of the tissue and wherein the second ultrasound image data comprises a second subset of voxels of ultrasound image data of the tissue, the second subset of voxels having a higher voxel-density in the region of interest than the first subset of voxels. By doing so, the combined system of Hyun would have generated an image registration between a CT image and an ultrasound image has been introduced to compensate for inherent deficiencies of the ultrasound image (paragraph 003 of Hyun).
11. Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Claus in view of RAJAGOPAL et al. U.S. Patent Application No. US 20230410301 (hereinafter RAJAGOPAL).
Regarding claim 10, Claus discloses the method according to claim 1.
However, RAJAGOPAL et al. (US 20230410301) working in the same field of endeavor teaches wherein the first ultrasound image data is two-dimensional ultrasound image data obtained in a first plane and the second ultrasound image data is two-dimensional image data to be obtained in a second plane, and wherein determining the region of interest comprises determining the second plane by performing an optimization procedure that optimizes for the first plane and the second plane being close to perpendicular to each other and for the second plane comprising a high number and/or density of the structural elements (Each image 125 depicts a plane that it parallel to other planes depicted in other images 125 corresponding to the subject and object of interest. Each of the multiple images 125 may further correspond to a different distance along a perpendicular axis to the plane; paragraphs 39, 40, 42, 46, 55, Figure 5 illustrating a comparison of predicted histograms for sextant and lesion volumes). Such an arrangement provides user convenience.
Thus, it would have been obvious to one having ordinary skill in the art at the time of Applicant’s invention to have combined the system of Claus as taught by RAJAGOPAL, since doing so would have predictably and advantageously provided user convenience.
Information Disclosure Statement
12. The information disclosure statement (IDS) submitted on 03/20/2024 was filed in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the information disclosure statement is being considered by the examiner.
Cited Art
13. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
14. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALLEN H NGUYEN whose telephone number is (571)270-1229. The examiner can normally be reached M-F 7 am-4 pm.
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/ALLEN H NGUYEN/Primary Examiner, Art Unit 2683
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