DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claim 5 is objected to because of the following informalities: the claim includes a period in the mid claim. Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation is: “creating an object MR image in an MRI simulator unit” in claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
35 U.S.C. 101 requires that a claimed invention must fall within one of the four eligible categories of invention (i.e. process, machine, manufacture, or composition of matter) and must not be directed to subject matter encompassing a judicially recognized exception as interpreted by the courts. MPEP 2106. Three categories of subject matter are found to be judicially recognized exceptions to 35 U.S.C. § 101 (i.e. patent ineligible) (1) laws of nature, (2) physical phenomena, and (3) abstract ideas. MPEP 2106(II). To be patent-eligible, a claim directed to a judicial exception must as whole be directed to significantly more than the exception itself. See 2014 Interim Guidance on Patent Subject Matter Eligibility, 79 Fed. Reg. 74618, 74624 (Dec. 16, 2014). Hence, the claim must describe a process or product that applies the exception in a meaningful way, such that it is more than a drafting effort designed to monopolize the exception. Id
Claims 1-12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., an abstract idea) without significantly more. Claim 1 is directed to creating an object MR image in an MRI simulator unit; performing an image/parameter comparison of the object MR image and parameter(s) thereof with a second MR image and/or a corresponding set of parameters, providing automatic feedback on the image/parameter comparison and providing the same in a user interface of the MRI simulator unit, without additional elements that are sufficient to amount to significantly more than the judicial exception. Specifically, creating an object MR image in an MRI simulator unit, is referring to gathering data under insignificant Extra-solution activity e.g. pre-solution activity (MPEP 2106.05(g)), and the MRI simulator is merely referring to a machine that contributes only nominally or insignificantly to the execution of the claimed method, performing an image/parameter comparison of the gathered MR images, is referring to comparing by mental process of abstract idea, through visually observing the gathered data, the concepts are performed in the human mind (including an observation, evaluation, judgment, opinion) (see MPEP § 2106.04(a)(2), subsection III), and providing automatic feedback on the image/parameter comparison, is referring to another insignificant Extra-solution activity specifically, a post-solution activity of performing an action post comparison of the data. An example of pre-solution activity is a step of gathering data for use in a claimed process, e.g., a step of obtaining information about credit card transactions, which is recited as part of a claimed process of analyzing and manipulating the gathered information by a series of steps in order to detect whether the transactions were fraudulent. An example of post-solution activity is an element that is not integrated into the claim as a whole, e.g., a printer that is used to output a report of fraudulent transactions, which is recited in a claim to a computer programmed to analyze and manipulate information about credit card transactions in order to detect whether the transactions were fraudulent (MPEP 2106.05(g)). Therefore, claim 1, meets the requirement of the step 2A, prong one of the guidelines for including an abstract idea.
The claim is then considered under step 2A, prong two, for integrating the judicial exception into a practical application. Limitations that the courts have found indicative that an additional element (or combination of elements) may have integrated the exception into a practical application include:
• An improvement in the functioning of a computer, or an improvement to other technology or technical field, as discussed in MPEP §§ 2106.04(d)(1) and 2106.05(a);
• Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, as discussed in MPEP § 2106.04(d)(2);
• Implementing a judicial exception with, or using a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim, 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, as discussed in MPEP § 2106.05(e).
The courts have also identified limitations that did not integrate a judicial exception into a practical application:
• Merely reciting the words "apply it" (or an equivalent) with the judicial exception, or merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea, as discussed in MPEP § 2106.05(f);
• Adding insignificant extra-solution activity to the judicial exception, as discussed in MPEP § 2106.05(g); and
• Generally linking the use of a judicial exception to a particular technological environment or field of use, as discussed in MPEP § 2106.05(h).
Based on the above conditions, Examiner does not believe that the language of claim 1 renders any of the qualifying conditions above. In fact, the limitations of claim 1 tend to lean more toward conditions that are not qualified i.e. “Generally linking the use of a judicial exception to a particular technological environment or field of use, as discussed in MPEP § 2106.05(h)”. Therefore claim 1 fails step 2A, prong two.
Additionally, claim 1 is considered under step 2B to include additional elements that amount to significantly more than the judicial exception. Limitations that the courts have found to qualify as "significantly more" when recited in a claim with a judicial exception include:
i. Improvements to the functioning of a computer, e.g., a modification of conventional Internet hyperlink protocol to dynamically produce a dual-source hybrid webpage, as discussed in DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1258-59, 113 USPQ2d 1097, 1106-07 (Fed. Cir. 2014) (see MPEP § 2106.05(a));
ii. Improvements to any other technology or technical field, e.g., a modification of conventional rubber-molding processes to utilize a thermocouple inside the mold to constantly monitor the temperature and thus reduce under- and over-curing problems common in the art, as discussed in Diamond v. Diehr, 450 U.S. 175, 191-92, 209 USPQ 1, 10 (1981) (see MPEP § 2106.05(a));
iii. Applying the judicial exception with, or by use of, a particular machine, e.g., a Fourdrinier machine (which is understood in the art to have a specific structure comprising a headbox, a paper-making wire, and a series of rolls) that is arranged in a particular way to optimize the speed of the machine while maintaining quality of the formed paper web, as discussed in Eibel Process Co. v. Minn. & Ont. Paper Co., 261 U.S. 45, 64-65 (1923) (see MPEP § 2106.05(b));
iv. Effecting a transformation or reduction of a particular article to a different state or thing, e.g., a process that transforms raw, uncured synthetic rubber into precision-molded synthetic rubber products, as discussed in Diehr, 450 U.S. at 184, 209 USPQ at 21 (see MPEP § 2106.05(c));
v. Adding a specific limitation other than what is well-understood, routine, conventional activity in the field, or adding unconventional steps that confine the claim to a particular useful application, e.g., a non-conventional and non-generic arrangement of various computer components for filtering Internet content, as discussed in BASCOM Global Internet v. AT&T Mobility LLC, 827 F.3d 1341, 1350-51, 119 USPQ2d 1236, 1243 (Fed. Cir. 2016) (see MPEP § 2106.05(d)); or
vi. Other meaningful limitations beyond generally linking the use of the judicial exception to a particular technological environment, e.g., an immunization step that integrates an abstract idea of data comparison into a specific process of immunizing that lowers the risk that immunized patients will later develop chronic immune-mediated diseases, as discussed in Classen Immunotherapies Inc. v. Biogen IDEC, 659 F.3d 1057, 1066-68, 100 USPQ2d 1492, 1499-1502 (Fed. Cir. 2011) (see MPEP § 2106.05(e)).
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:
i. Adding the words "apply it" (or an equivalent) with 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 1984 (see MPEP § 2106.05(f));
ii. Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984 (see MPEP § 2106.05(d));
iii. Adding insignificant extra-solution activity to the judicial exception, e.g., mere data gathering in conjunction with a law of nature or abstract idea such as a step of obtaining information about credit card transactions so that the information can be analyzed by an abstract mental process, as discussed in CyberSource v. Retail Decisions, Inc., 654 F.3d 1366, 1375, 99 USPQ2d 1690, 1694 (Fed. Cir. 2011) (see MPEP § 2106.05(g)); or
iv. Generally linking the use of the judicial exception to a particular technological environment or field of use, e.g., a claim describing how the abstract idea of hedging could be used in the commodities and energy markets, as discussed in Bilski v. Kappos, 561 U.S. 593, 595, 95 USPQ2d 1001, 1010 (2010) or a claim limiting the use of a mathematical formula to the petrochemical and oil-refining fields, as discussed in Parker v. Flook, 437 U.S. 584, 588-90, 198 USPQ 193, 197-98 (1978) (MPEP § 2106.05(h)).
Based on the above conditions, Examiner is unable to identify one or more claimed elements that amount to significantly more than the judicial exception. The claim language leaning over to non-qualifying condition i.e. “ii. Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception”. Therefore claim 1 also fails step 2B as well, and is not eligible under 101.
Regarding claim 2, it recites, the image/parameter comparison is performed between the object MR image and/or parameter(s) thereof and a set of parameters being at least position and/or orientation of the reference plane, preferably both position and orientation of the reference plane, as further referring to comparing by mental process of observing, analyzing and judging the gathered data. The claim is therefore not eligible.
Regarding claim 3, it recites, the image/parameter comparison is performed between the object MR image with parameter(s) thereof and a second MR image with a corresponding set of parameters, as further referring to comparing by mental process of observing, analyzing and judging the gathered data. The claim is therefore not eligible.
Regarding claim 4, it recites, the comparison is based on at least comparing the anatomical position of the object MR image and the anatomical position of the second MR image, as further referring to comparing by mental process of observing, analyzing and judging the gathered data. The claim is therefore not eligible.
Regarding claim 5, it recites, the comparison is based on one or more parameters of the object MR image and a corresponding one or more parameters of the second MR image of the object MR image and/or parameter(s) thereof and the second MR image and/or the corresponding set of parameters, as further referring to comparing by mental process of observing, analyzing and judging the gathered data. The claim is therefore not eligible.
Regarding claim 6, it recites, the second MR image and/or corresponding set of parameters functioning as a reference is created in the MRI simulator unit, or by a search to find an already existing MR image or corresponding set of parameters, as further referring to gathering data under insignificant extra-solution activity through alternative sources. The claim is therefore not eligible.
Regarding claim 7, it recites, the comparison is based on coordinates (X, Y, Z) for at least one position of the object MR image and the second MR image, respectively, optionally for several positions of the object MR image and the second MR image, respectively, as referring to mental process of observing, analyzing and judging the gathered position or coordinate data. The claim is therefore not eligible.
Regarding claim 8, it recites, the comparison is based on comparing corresponding peripheral portions of the object MR image and the second MR image, referring to mental process of comparing by human mind. The claim is therefore not eligible.
Regarding claim 9, it recites, the comparison is based on at least one of the following parameters: scan time, image quality / noise / signal to noise ratio, resolution, contrast, artifacts or SAR, preferably at least contrast, referring to alternative method comparing of data by mental process. The claim is therefore not eligible.
Regarding claim 10, it recites, wherein the comparison is based on at least scan time, image quality or resolution, or a combination thereof, as referring to comparing of data by mental process through observation, analysis and judgment. The claim is therefore not eligible.
Regarding claim 11, it recites, the comparison is based on the anatomical position of the object MR image and the anatomical position of the second MR image, and also on at least one parameter of scan time, image quality and resolution, preferably on all of scan time, image quality and resolution, as referring to comparing of data by mental process through observation, analysis and judgment. The claim is therefore not eligible.
Regarding claim 12, it recites, the automatic feedback is provided as a scoring or marking, preferably with a scoring and/or marking for each parameter used in the image comparison, referring to insignificant post-solution activity as an element that is not integrated into the claim as a whole, e.g., a printer that is used to output a report of fraudulent transactions, inherently as scoring or marking the transaction, which is recited in a claim to a computer programmed to analyze and manipulate information about credit card transactions in order to detect whether the transactions were fraudulent (MPEP 2106.05(g)). The claim is therefore not eligible.
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 2, 9-12 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, the claims 2, 9, 11, 12 variously recite the broad recitation of alternative comparison or feedback factors, and the claim also recites “preferably . . .” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Therefore, the claim is vague and confusing because it is unclear what feature or element is further limited by this language.
For the purpose of this office action the claims will be treated as reciting the broader limitations.
Claim 10 depends from an indefinite base claim and is thus itself indefinite.
Claim 5 is 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. The claim seems to be referring to alternative based comparison methods however, the current language of the claim is convoluted and unclear. Therefore, the claim is vague and confusing because it is unclear what feature or element is further limited by this language. For the purposes of this office action, the claim will be treated as claiming only “the comparison is based on one or more parameters of the object MR image and a corresponding one or more parameters of the second MR image”.
Claim 7 is 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. The recited phrase “optionally, for several positions . . .” is referring to alternative number of positions that is in contradiction with the first number of positions. Therefore, the claim is vague and confusing because it is unclear what feature or element is further limited by this language. For the purposes of this office action, the claim will be treated as claiming “the comparison is based on coordinates for one or more position of . . .”.
Claim limitation “creating an object in an MRI simulator unit” in claim 1 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Specifically, applicant fails to set forth an adequate disclosure to particularly point out and distinctly claim the invention as required by the 35 U.S.C. 112(b) for creating the MR image is disclosed (MPEP 2161(II)). Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claims 2-12 depend from a rejected base claim under 112(b) for inadequate disclosure and are therefore themselves rejected for the same reasons.
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 1-12 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 claims 1-12 contain 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. Applicant’ specification does not disclose steps of creating an image, the comparison of images/parameter, and the feedback mechanism of the claim 1.
Claims 2-12 depend from claim 1 and lack written description requirement themselves.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
Claims 1, 4, 5 and 7-12 are rejected under 35 U.S.C. 102(a)(1) as anticipated by US 11,416,653 B2 to Downs et al (hereinafter ‘Downs’) or, in the alternative, under 35 U.S.C. 103 as obvious over US 10,663,547 B2 to Grodzki et al (hereinafter ‘Grodzki’).
Regarding claim 1, Downs discloses a method in the field of a magnetic resonance imaging (MRI) (column 2, lines 41-43, a method comprising comparing the simulated magnetic resonance image with an output of a clinical MRI machine), said method comprising creating an object MR image in an MRI simulator unit (Column 14, lines 9-11, wherein at step 630, the MRI simulator may perform a simulated scan using the numerical model as input to generate a simulated magnetic resonance image); performing an image/parameter comparison of the object MR image and parameter(s) thereof with a second MR image and/or a corresponding set of parameters functioning as a reference (column 14, lines 19-21, wherein at step 650, the reconstructed estimate may be compared to the known tissue properties of the numerical model, as tissue properties of another/second MR image); wherein the comparison is based on at least comparing the anatomical position of the object MR image and/or parameter(s) thereof and the second MR image and/or the corresponding set of parameters (column 8, lines 51-58, wherein the data array may be populated with default tissue property values corresponding to one or more default tissue properties. Additionally, each cell in the data array may be associated with one or more coordinate values that correspond to the position of the cell within the array and/or identify the region of the brain to which the cell corresponds), said method also comprising - providing automatic feedback on the image/parameter comparison (column 14, lines 22-28, wherein at step 660, based on differences between the reconstructed estimate of the tissue property and the known tissue properties of the numerical model, the pulse sequence may be adjusted) and providing the same in a user interface of the MRI simulator unit (column 13, lines 37-40, wherein if the output is formatted to correspond to an output of a clinical or simulated MRI scan, the system may display the generated numerical model as the output of a simulated, as feedback of the user interface, or clinical MRI scan.). Downs additionally disclose generating MR images and using them as part of post-processing e.g. comparison (column 2, lines 5-8, wherein the generated model may be used as an input to an MRI simulator, and MR images may be generated based on the model. The generated model may also be used as an input to post-processing and analyses software). In as much as Applicant disagrees with Examiner’s assessment, Grozski discloses comparing simulated MR image with another MR image (column 7, lines 21-27, wherein using the test measurement protocol, an MR image is simulated in S42 by solving the Bloch equations, and the corresponding contrast ratios for the anatomical regions in the simulated image, as the first image, are calculated in step S43. In a further embodiment variant, contrast ratios are simulated directly. In step S44, the simulated contrast ratios are compared with the contrast ratios that were determined for the first image, as the second image of the claim 1). Downs and Grodzki are combinable because they both disclose detecting and setting measurement protocols for the MR apparatus. Therefore, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to combine the comparing of the simulated and original MR images of Grodzki’s method with Downs’ because it affords the advantage that clinical findings for a patient that were recorded using a different MR system, e.g. in a different hospital at a different time, may be more easily compared with the present condition of the patient (column 4, lines 40-44).
Regarding claim 4, in the combination of Downs and Grodzki, Downs discloses wherein the comparison is based on at least comparing the anatomical position of the object MR image and the anatomical position of the second MR image (column 2, lines 41-46, wherein the method comprises comparing the simulated magnetic resonance image with an output of a clinical MRI machine and calibrating the clinical MRI machine based on differences between the simulated magnetic resonance image and the output of the clinical MRI machine).
Regarding claim 5, in the combination of Downs and Grodzki, Downs discloses wherein the comparison is based on one or more parameters of the object MR image and a corresponding one or more parameters of the second MR image (column 3, line 67 through column 4, line 2, wherein comparing the reconstructed estimate of the tissue property values to the tissue property values on which the numerical model is based, as part of the original MR image).
Regarding claim 7, in the combination of Downs and Grodzki, Downs discloses wherein the comparison is based on coordinates (X, Y, Z) for at least one position of the object MR image and the second MR image, respectively, optionally for several positions of the object MR image and the second MR image, respectively (column 8, lines 51-58, wherein the data array may be populated with default tissue property values corresponding to one or more default tissue properties. Additionally, each cell in the data array may be associated with one or more coordinate values, as inherently based on coordinate of an object, that correspond to the position of the cell within the array and/or identify the region of the brain to which the cell corresponds).
Regarding claim 8, in the combination of Downs and Grodzki, Downs discloses wherein the comparison is based on comparing corresponding peripheral portions of the object MR image and the second MR image (column 9, lines 22-27, wherein a boundary of a segment may be modified by adding or removing cells adjacent to an initial boundary, as the peripheral of the object consideration, of the segment, as input object image in step 610 of fig. 6 for comparison. For example, cells may be added to the segment such that the region of the head to which the segment corresponds is expanded by 2 mm).
Regarding claim 9, in the combination of Downs and Grodzki, Grodzki discloses wherein the comparison is based on at least one of the following parameters: scan time, image quality / noise / signal to noise ratio, resolution, contrast, artifacts or SAR, preferably at least contrast (column 7, lines 21-27, wherein using the test measurement protocol, an MR image is simulated in S42 by solving the Bloch equations, and the corresponding contrast ratios for the anatomical regions in the simulated image are calculated in step S43. In a further embodiment variant, contrast ratios are simulated directly. In step S44, the simulated contrast ratios are compared with the contrast ratios that were determined for the first image.).
Regarding claim 10, in the combination of Downs and Grodzki, Downs discloses wherein the comparison is based on at least scan time, image quality or resolution, or a combination thereof (column 8, lines 3-5, wherein That is, the number of cells in the array may be selected to correspond to a resolution of a clinical MRI scan and/or the output of a software-defined MRI simulator.).
Regarding claim 11, in the combination of Downs and Grodzki, Downs discloses wherein the comparison is based on the anatomical position of the object MR image and the anatomical position of the second MR image, and also on at least one parameter of scan time, image quality and resolution, preferably on all of scan time, image quality and resolution (column 8, lines 3-5, wherein That is, the number of cells in the array may be selected to correspond to a resolution of a clinical MRI scan and/or the output of a software-defined MRI simulator.)
Regarding claim 12, in the combination of Downs and Grodzki, Downs discloses wherein the automatic feedback is provided as a scoring or marking, preferably with a scoring and/or marking for each parameter used in the image comparison (column 4, lines 54-59, wherein finally, an MRI measurement method may be validated, as inherently determined by some software validity marking, by using a software-defined MRI simulator to generate an image based on a computer model of the tissue having known tissue properties—a “numerical model”—and comparing the generated image to the known properties of the model.).
Claims 2 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Downs in view of Grodzki and further in view of US 20190033419 A1 to Golay et al (hereinafter ‘Golay’).
Regarding claim 2, in the combination of Downs and Grodzki, Downs discloses wherein the image/parameter comparison is performed between the object MR image and/or parameter(s) thereof and a set of parameters being at least position and/or orientation of the reference plane, preferably both position of the reference plane. (Column 8, lines 51-58, wherein the data array may be populated with default tissue property values corresponding to one or more default tissue properties. Additionally, each cell in the data array may be associated with one or more coordinate values that correspond to the position of the cell within the array and/or identify the region of the brain to which the cell corresponds). Downs and Grodzki do not specifically disclose the set of parameters being at least orientation of the reference plane. Golay discloses discloses the set of parameters being at least orientation of the reference plane, in the comparing (Para [0045], wherein generating a simulated image of the phantom using the determined position and orientation, and comparing the simulated image to the uploaded data to generate calibration results; forwarding calibration results to the imaging center for performing calibration of the device at the imaging center according to the calibration results). Downs, Grodzki and Golay are combinable because they all disclose detecting and setting measurement protocols for the MR apparatus. Therefore, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to combine the set of parameters being at least orientation of the reference plane in comparing of Golay’s method with Downs’ and Grodzki’s for calibration purposes of the device (Para [0045]).
Regarding claim 3, Downs and Grodzki, do not specifically disclose the image/parameter comparison is performed between the object MR image with parameter(s) thereof and a second MR image with a corresponding set of parameters. Golay discloses the image/parameter comparison is performed between the object MR image with parameter(s) thereof and a second MR image with a corresponding set of parameters (para [0144], wherein the collected data is uploaded to the server where it is registered and compared with the reference “digital phantom” (or reference image) in order to identify orientation and phantom position. The reference data could be static or dynamically created on-the-fly. A simulated ASL image is created as described above in the section dealing with optimizing flow geometry of the phantom. This time, however, the orientation and position of the phantom within the MRI scanner in the uploaded image is used to ensure that the simulated image is directly comparable with the real data). Downs, Grodzki and Golay are combinable because they all disclose detecting and setting measurement protocols for the MR apparatus. Therefore, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to combine the image/parameter comparison is performed between the object MR image with parameter(s) thereof and a second MR image with a corresponding set of parameters of Golay’s method with Downs’ and Grodzki’s in order to generate calibration results for the device (Para [0144]).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Downs in view of Grodzki and further in view of US 8,386,214 B2 to Nitz.
Regarding claim 6, Downs and Grodzki do not specifically disclose wherein the second MR image and/or corresponding set of parameters functioning as a reference is created in the MRI simulator unit as a reference or wherein the MR simulator unit performs a search to find an already existing MR image or corresponding set of parameters in a platform of the MRI simulator unit as a suitable reference. Nitz discloses wherein the MR simulator unit performs a search to find an already existing MR image or corresponding set of parameters in a platform of the MRI simulator unit as a suitable reference (column 3, lines 12-18, wherein for better correlation of the automatically suggested simulated image plane and the image plane selected by the examination person, the previously used MR exposures (for example overview exposures) could be used, wherein these are compared with the predetermined data set in order to select the image plane for the position of the MR image to be simulated using the comparison). Downs, Grodzki and Nitz are combinable because they all disclose detecting and setting measurement protocols for the MR apparatus. Therefore, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to combine the MR simulator unit performs a search to find an already existing MR image or corresponding set of parameters in a platform of the MRI simulator unit as a suitable reference of Nitz’s method with Downs’ and Grodzki’s so that to incorporate local variations of previous stored image scan be taken into account in a simulation of the MR image given (column 3, lines 9-10).
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/SHERVIN K NAKHJAVAN/Primary Examiner, Art Unit 2672
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