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 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 use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are: “modelling unit”, “x-ray image acquisition unit”, “respiratory state unit”, “signal modification unit” in claim 15.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends 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 remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
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 1-15 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.
Regarding claim 1, the claim recites “method for generating a dark field X-ray (DAX) model” in the preamble and then “inputting a plurality of training DAX images… to the DAX model” immediately thereafter. It is unclear how a plurality of training DAX images can be input to the DAX model if it has not yet been generated as per the preamble. For examination purposes, the preamble has been interpreted as “method for using a dark field X-ray (DAX) model”.
As a result of dependence on claim 1, subsequent dependent claims 2-6 and 8-14 are also rejected as indefinite.
Regarding claim 6, the claim recites “the subject” in ll. 2 which lacks antecedent basis in the claims. For examination purposes, this limitation has been interpreted as “a subject”.
Regarding claim 15, the claim recites “a respiratory state of the subject” in ll. 7. It is unclear whether or not this limitation refers to the previously disclosed “a respiration state” of ll. 4. For examination purposes, this limitation has been interpreted as “the respiratory state of the subject”.
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.
Claim(s) 1-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The independent claim(s) recite(s) a method (claim 1), a method (claim 7), and a system (claim 15); thus, these claims pass step 1 of the subject matter eligibility test since they are directed towards a process and a system.
As a whole, claim 1 recites a process of inputting a plurality of training images to a dark field x-ray (DAX) model, receiving a plurality of predicted respiratory states and predicted respiratory disease grades from the model, determining parameter values of the model based on the predicted states and disease grades. This process has been determined to be an abstract idea in the form of a mental process; it is fully capable of being performed in the human mind. For example, this process could be performed by a physician analyzing DAX signals and images with the aid of pen and paper (MPEP 2106.04(a)(2)(III)). The claimed DAX model can be interpreted as being a human mind knowledgeable in the analysis of DAX signals and images. Since all of these steps are capable of being performed in the human mind, this claim passes Step 2A prong one of the eligibility test.
This judicial exception is not integrated into a practical application because there are no additional elements recited which integrate the invention into a practical application. Although the claim recites that the method is “computer implemented”, such limitations do not amount to significantly more because they merely serve to limit the judicial excepttion to the computer field (MPEP 2106.05(h)). The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because such elements are not recited, as explained above. Thus, this claim fails Step 2A prong two and Step 2B of the eligibility test, and this claim is not eligible subject matter under 35 U.S.C. 101.
Subsequent dependent claims 2-6 and 8-14 merely further specify additional mental steps and/or details of the mental steps.
As a whole, claim 7 recites a process of obtaining a DAX signal of a subject, wherein a DAX image corresponds to the DAX signal, determining the respiratory state of the subject based on the DAX signal, and acquiring a modified DAX signal of the subject based on input to the DAX model. This process has been determined to be an abstract idea in the form of a mental process; it is fully capable of being performed in the human mind. For example, this process could be performed by a physician analyzing DAX signals and images with the aid of pen and paper (MPEP 2106.04(a)(2)(III)). The claimed DAX model can be interpreted as being a human mind knowledgeable in the analysis of DAX signals and images. Since all of these steps are capable of being performed in the human mind, this claim passes Step 2A prong one of the eligibility test.
This judicial exception is not integrated into a practical application because there are no additional elements recited which integrate the invention into a practical application. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because such elements are not recited, as explained above. Thus, this claim fails Step 2A prong two and Step 2B of the eligibility test, and this claim is not eligible subject matter under 35 U.S.C. 101.
As a whole, claim 15 recites a process of obtaining a DAX signal of a subject, wherein a DAX image corresponds to the DAX signal, determining the respiratory state of the subject based on the DAX signal, and acquiring a modified DAX signal of the subject based on input to the DAX model. This process has been determined to be an abstract idea in the form of a mental process; it is fully capable of being performed in the human mind. For example, this process could be performed by a physician analyzing DAX signals and images with the aid of pen and paper (MPEP 2106.04(a)(2)(III)). The claimed DAX model can be interpreted as being a human mind knowledgeable in the analysis of DAX signals and images. Furthermore, the claimed “modelling unit”, “respiratory state unit”, and “signal modification unit” can all be interpreted as being a human mind knowledgeable in the analysis of DAX signals and images. Since all of these steps are capable of being performed in the human mind, this claim passes Step 2A prong one of the eligibility test.
This judicial exception is not integrated into a practical application because there are no additional elements recited which integrate the invention into a practical application. Although the claim recites an “x-ray acquisition unit”, the Examiner submits that such limitations amount to insignificant extra-solution activity in the form of mere data gathering (MPEP 2106.05(g)) because the x-ray acquisition unit is used to acquire the DAX signal which is being analyzed in the mental process. As such, this limitation does not integrate the invention into a practical application.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because such elements are not recited, as explained above. Thus, this claim fails Step 2A prong two and Step 2B of the eligibility test, and this claim is not eligible subject matter under 35 U.S.C. 101.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Yaroshenko et al. (EP 3656308) discloses apparatus for alveoli-based visualization in dark field x-ray imaging (Abstract).
Koehler et al. (EP 3622891) discloses a calculation device for comparing dark-field x-ray images for determining ventilation defects (Abstract).
Sabczysnki et al. (EP 3496109) discloses oscillatory dark field imaging (Abstract).
Proksa et al. (US 2018/0271465) discloses generating a lung condition map and that imaging the lungs using the dark-field can provide information on the status of COPD (Abstract).
Kiely (US 10970926) discloses lung-volume-gated x-ray imaging (Abstract).
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/A.A.G./Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792