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 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 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites the phrase “a control circuit in signal communication with the X-ray source and the X-ray detector, the control circuit capable to generate a phase-contrast enhanced X-ray image of the specimen based on the detected X-ray EM radiation including the interference pattern”. The Specification describes the scope of the “control circuit” as including:
“a general-purpose computing device configured by a computer program (e.g., a general-purpose computer configured by a computer program that at least partially carries out processes and/or devices described herein or a microprocessor configured by a computer program that at least partially carries out processes and/or devices described herein” (Spec, [0034]).
However, the disclosure fails to provide the corresponding computer program, workflow, or algorithm necessary to enable the function. Accordingly, the claim lack written description. The same issue arises with the limitations of claims 10-14 and 16:
“wherein the control circuit is capable to identify a microcalcification of the specimen based on the phase-contrast enhanced X-ray image” (claim 10);
“wherein the control circuit is capable to determine a property of the microcalcification of the specimen based on the phase-contrast enhanced X-ray image, wherein the property of the microcalcification comprises at least one of a shape of the microcalcification, a size of the microcalcification, a location of the microcalcification, and a composition of the microcalcification” (claim 11);
“wherein the control circuit is capable to determine a classification of a microcalcification of the specimen based on the property of the microcalcification, wherein the classification comprises a first category of microcalcifications or a second category of microcalcifications” (claim 12);
“wherein the classification of the microcalcification is further based on data comprising at least one of an age of a subject, a health history of the subject, and a genetic predisposition of the subject” (claim 13);
“wherein the control circuit is capable to identify an amount of spiculations of the microcalcification of the specimen based on the phase-contrast enhanced X-ray image” (claim 14); and
“a control circuit in signal communication with the X-ray source and the X-ray detector, wherein the focal spot size, the second distance, and the spatial resolution of the X-ray detector are configured to enable the control circuit to generate a phase-contrast enhanced X-ray image of the specimen” (claim 16).
Accordingly, the claim is rejected under the same rationale, for failing to provide the necessary computer program, workflow, or algorithm necessary to enable the claimed functions. The balance of claims are rejected based on dependence.
Claims 1-20 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.
Claim 1 recites the phrase “a control circuit in signal communication with the X-ray source and the X-ray detector, the control circuit capable to generate a phase-contrast enhanced X-ray image of the specimen based on the detected X-ray EM radiation including the interference pattern.” This limitation is set forth in purely functional terms: it claims the result to be achieved without reciting any algorithm, workflow, or methodology by which the control circuit accomplishes the result. The claim therefore cover all means of performing the recited function. The specification does not cure this deficiency, as it merely restates the desired outcome while being absent any algorithm, workflow of methodology. While the specification describes in [0034-0035] the “control circuit” may refer to any of a number of different types of hardware circuitry configurations, the control circuitry remains a black box. Disclosing what the circuit does without disclosing how it does it amounts to a lack of enablement of the invention. See MPEP § 2161.01, 2164.01. Considering the In re Wands factors: The breadth of the claim is broad. The field is unpredictable with a variety of potential algorithms that depend of the nature of the collected data. The specification provides no direction on how the function is performed, and substantial work would be needed to develop a suitable algorithm.
Regarding claims 10-15, 16, and 19, the same rationale applies to the functionality ascribed to the control circuit of claims. For example, claim 10 recites the phrase “wherein the control circuit is capable to identify a microcalcification of the specimen based on the phase-contrast enhanced X-ray image” lacks enablement because the specification does not provide any algorithm, workflow, or methodology by which the control circuit accomplishes the result. The breadth of each of the claims is broad. The field is unpredictable with a variety of potential algorithms that depend of the nature of the collected data defining the type of algorithm that could be successful. The specification provides no direction on how the function is performed, and substantial work would be needed to develop the suitable algorithm(s).
Accordingly, the balance of claims are rejected based on dependence.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 2, 8, 9, 16-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over BRAJME et al. (US 20090238334 A1).
Regarding claim 1, BRAJME discloses a phase-contrast enhanced X-ray imaging system (FIG 1, imaging system 1) comprising:
a substrate capable to hold a specimen and comprising a first side and a second side (couch 120 having a first side which supports a patient 110, and a second opposing side; [0061]);
an X-ray source positioned a first distance and configured to emit X-ray EM radiation towards the substrate and configured to emit X-ray EM radiation towards the first side of the substrate (radiation head 20 has a source 30 at a first distance and emits x-rays toward patient 110; FIG. 2);
an X-ray detector positioned a second distance from the first side of the substrate and opposing the X-ray source, the second distance enabling X-ray EM radiation emitted by the X-ray source to form an interference pattern, wherein the X-ray detector is capable to receive and detect the X-ray EM radiation including the interference pattern (detector 40 receives radiation beams 32/33 having passed through object 110; [0061]); and
a plurality of control circuits in signal communication with the X-ray source and the X-ray detector, the control circuit configured to generate a phase-contrast enhanced X-ray image of the specimen based on the detected X-ray EM radiation including the interference pattern (source controller 26 for controlling x-ray source, [0069] I/O unit 52 for interfacing between internal and external equipment, [0103]; image processor includes DPC processor 64, [0105]; FIG. 9).
BRAJME does not specifically disclose the plurality of control circuits as a single control circuit in communication with the source and detector. Having a single control circuit as opposed to a plurality of control circuits is known in the art and would have been obvious to one of ordinary skill at the time of filing with the benefit of simplified architecture. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
Regarding claim 2, BRAJME discloses wherein the second distance is sufficient such that the interference pattern develops to a level detectable by the X-ray detector (edge enhancement is a product of interference; [0040, 0085]).
Regarding claim 8, BRAJME discloses wherein the specimen is a tissue sample (patient 110; FIG 1).
Regarding claim 9, BRAJME discloses a sample wherein the tissue sample is capable of being a breast biopsy tissue sample (breast tissue biopsy strongly suggested in [0130]; a claim is only limited by positively recited elements, and the claim does not positively recite the sample; see MPEP 2115). Furthermore, providing the sample as a breast biopsy is well-known and obvious to one of ordinary skill in the art at the time of filing.
Regarding claim 16, BRAJME discloses a phase-contrast enhanced X-ray imaging system (FIG 1-2) comprising:
a substrate capable to hold a specimen and comprising a first side and a second side (couch 120 having a first side which supports a patient 110, and a second opposing side; [0061]);
an X-ray source comprising a focal spot size, the X-ray source positioned a first distance from the first side of the substrate and capable to emit X-ray EM radiation towards the first side of the substrate (source 90/100 inherently has a focal spot size ([0086]) which is positioned a first distance from a first side of the couch 120; FIG 1);
an X-ray detector comprising a spatial resolution, the X-ray detector positioned a second distance from a first side of the substrate and opposing the X-ray source, the second distance enabling X-ray EM radiation emitted by the X-ray source to form an interference pattern, wherein the X-ray detector is capable to receive the X-ray EM radiation and detect the interference pattern (x-ray detector 40 detects a phase-contrast image of the patient which inherently comprises the detected interference pattern; [0081]); and
a control circuit in signal communication with the X-ray source and the X-ray detector, wherein the focal spot size, the second distance, and the spatial resolution of the X-ray detector are configured to enable the control circuit to generate a phase-contrast enhanced X-ray image of the specimen source (controller 26 for controlling x-ray source, [0069] I/O unit 52 for interfacing between internal and external equipment, [0103]; image processor includes DPC processor 64, [0105]; FIG. 9).
BRAJME does not specifically disclose the plurality of control circuits as a single control circuit in communication with the source and detector. Having a single control circuit as opposed to a plurality of control circuits is known in the art and would have been obvious to one of ordinary skill at the time of filing with the benefit of simplified architecture. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
Regarding claim 17, BRAMJE discloses wherein the phase-contrast enhanced X-ray image of the specimen is further based on the detected interference pattern and the received X-ray EM radiation (phase-contrast x-ray images are inherently based on the interference of diffracted EM radiation from the edges of a region of the sample).
Regarding claim 18, BRAJME discloses a sample wherein the tissue sample is capable of being a breast biopsy tissue sample (breast tissue biopsy strongly suggested in [0130]; a claim is only limited by positively recited elements, and the claim does not positively recite the sample; see MPEP 2115). Furthermore, providing the sample as a breast biopsy is well-known and obvious to one of ordinary skill in the art at the time of filing.
Claim(s) 3-7, 15, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over BRAJME et al. (US 20090238334 A1) in view of SHINDEN et al. (US 20090080609 A1).
Regarding claim 3, BRAJME does not disclose wherein the second distance is at least 25% of the first distance. In the same field of endeavor, SHINDEN discloses a phase-contrast enhanced x-ray imager comprising providing a distance between the source and subject (R1) as 0.15 < R1 < 5 m and subject and the detector (R2) as 0.5 < R2 < 2 m (thus R2 = 0.25 * R1), with the benefit of enhanced edge contrast of an object ([0066]). In light of the teachings of SHINDEN, it would have been obvious to one of ordinary skill in the art at the time of filing to combine with the teachings of BRAJME. Furthermore, selecting the optimal working ranges for an invention where the general conditions are provided would have been within the level of ordinary skill in the art at the time of filing.
Regarding claim 4, SHINDEN discloses wherein the second distance is at least 50% of the first distance ([0066]).
Regarding claim 5, SHINDEN discloses wherein the second distance is adjustable for controlling a field of view of the specimen ([0066]).
Regarding claim 6, SHINDEN discloses wherein the X-ray detector has a spatial resolution of at least 30 lp/mm (pixel size of image outputted 25 < A < 300 µm; [0069]).
Regarding claim 7, SHINDEN discloses wherein the X-ray source comprises a focal spot size of no greater than 30 µm (1 µm; [0069]).
Regarding claim 15, SHINDEN discloses wherein a focal spot size of the X-ray source, the second distance, and a spatial resolution of the X-ray detector are configured to enable the control circuit to generate the phase-contrast enhanced X-ray image ([0011, 0065-0069]).
Regarding claim 20, SHINDEN discloses wherein the spatial resolution of the X-ray detector is at least 30 lp/mm, the focal spot size of the X-ray source is no greater than 30 µm, and the second distance is at least 25% of the first distance (see also claims 3 and 6 above; [0066, 0069]).
Claim(s) 10-13 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over BRAJME et al. (US 20090238334 A1) in view of WANG et al.1 (NPL).
Regarding claims 10 and 19, BRAJME discloses the goal of identifying microcalcifications of the specimen based on the phase-contrast enhanced X-ray image (“Since microcalcifications of about 100 µm are the most critical objects in the breast tissue that may provide an indication for breast cancer, a high spatial resolution with the mammography system is therefore mandatory”; [0131]), but does not specify wherein the control circuit is configured to perform identification. In the same field of endeavor, WANG discloses a medical imaging system and method of classifying microcalcifications comprising providing a phase-contrast imaging of a collection of samples (x-ray grating interferometry) and providing a classification algorithm (and thus a control circuit) that inspects the sample based on properties including size ang shape (degree of scattering as a proxy for chemical composition; p. 3-4), with the benefit of detecting potential carcinoma in a sample. In light of the teachings of WANG, it would have been obvious to one of ordinary skill in the art at the time of the invention to combine with the teachings of BRAJME.
Regarding claim 11, WANG further discloses the control circuit is configured to determine a property of the microcalcification of the specimen based on the phase-contrast enhanced X-ray image, wherein the property of the microcalcification comprises at least one of a shape of the microcalcification, a size of the microcalcification, a location of the microcalcification, and a composition of the microcalcification (shape, size, composition; p. 4).
Regarding claim 12, WANG discloses wherein the control circuit is configured to determine a classification of a microcalcification of the specimen based on the property of the microcalcification, wherein the classification comprises a first category of microcalcifications or a second category of microcalcifications (p. 4).
Regarding claim 13, WANG does not disclose the classification of the microcalcification is further based on data comprising at least one of an age of a subject, a health history of the subject, and a genetic predisposition of the subject. However, biopsy classification based on common risk factors including age, patient history, and genetics amounts to the use of a known technique to improve similar methods (classification of microcalcifications) in the same way would have been obvious to one of ordinary skill in the art at the time of filing. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over BRAJME et al. (US 20090238334 A1) in view of WANG et al. (NPL), further in view of TAKEDA et al.2 (NPL).
Regarding claim 14, WANG discloses does not specify the control circuit is configured to identify an amount of spiculations of the microcalcification of the specimen based on the phase-contrast enhanced X-ray image. TAKEDA discloses a method of phase-contrast x-ray imaging of samples to determine essential features of a cancer, including microcalcification, spiculation, and soft tissue structures at high resolution (abstract), with the benefit of improved detection. In light of the teachings of TAKEDA, it would have been obvious to one of ordinary skill in the art at the time of filing to combine with the teachings of WANG and BRAJME.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
WIEDMANN et al. (US 20210244373 A1) discloses a phase-contrast x-ray detector but does not specify a substrate.
MAKIFUCHI et al. (US 20150131777 A1) discloses a method of identifying microcalcifications using absorption, phase-contrast, and small-angle scattering x-ray imaging.
KOTTLER (EP 2586373 A1) discloses a x-ray interferometer for x-ray imaging further comprising interference data.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CASEY BRYANT whose telephone number is (571)270-7329. The examiner can normally be reached M-F // 7-3P EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, UZMA ALAM can be reached at 571-272-3995. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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CASEY BRYANT
Primary Examiner
Art Unit 2884
/CASEY BRYANT/Primary Examiner, Art Unit 2884
1 WANG, Z., Hauser, N., Singer, G. et al. Non-invasive classification of microcalcifications with phase-contrast X-ray mammography. Nature Communications 5, 3797 (2014).
2 Tohoru Takeda et al., “Interferometric X-Ray Imaging of Breast Cancer Specimens at 51 keV X-Ray Energy”, 2004 Japanese Journal of Applied Physics 43 5652.
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