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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/23/2026 has been entered.
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(s) is/are:
Claim 1:
a wave detector
a data processing device
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.
Claim 1:
a wave detector has been interpreted to be an ultrasound detector, camera, infrared detector, ultraviolet detector, a LIDAR, radar or microwave antenna as set forth in Paragraph [0015] of the published application.
a data processing device has been interpreted to be an appropriately programmed microprocessor, computing cloud, ASIC, FPGA or the like with memory as set forth in Paragraph [0080] of the published application.
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 § 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 1-5, 7 and 9-22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 1 is rejected because it is unclear if the data received from the wave detector (line 13) is the detected position of the marker as now claimed. If so, it is unclear how the wave detector detects both when the wave detector is an ultrasound device and needs to be in acoustic contact with the tissue under investigation. Claim 21 is rejected because it is unclear if the data from a left and right breast is the same data set forth in Claim 1.
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.
Claim(s) 1-5, 7, 9-10, 12-18 and 20-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2021/0045700 to St. Pierre et al. “St. Pierre” in view of U.S. Publication No. 2022/0030172 to Hannemann et al. “Hannemann”, U.S. Publication No. 2019/0159751 to Fatemi et al. “Fatemi” and U.S. Publication No. 2017/0251991 to Wang et al. “Wang”.
As for Claims 1, 7, 18 and 20, St. Pierre discloses a system and method for screening breast tissue for cancer (e.g. malignant cells) (Abstract; Paragraph [0004]) comprising a compression system (e.g. displacement actuator) that includes a static breast platform and a moveable compression paddle that can move towards each other to compress and immobilize the breast (Paragraph [0020]). St. Pierre discloses wherein the system utilizes a number of sensors to monitor conditions of the breast and/or breast paddle to help reduce discomfort during compression where the sensors may include sensors that measure the distance or proximity to the breast, detect changes in features shapes or other characteristics or conditions of the breast and may include sensors that emit laser light in the visible or invisible spectrums, time of flight cameras or sensors, light detection and ranging (LIDAR) sensors, motion sensing systems, optical sensors and so on (e.g. wave detector; Paragraphs [0025]). Fig. 1A depicts various locations for the sensors including a tube head sensor 150 generally pointing down toward the compression paddle, a compression system sensor 154 disposed on the compression system and generally points forward toward the breast to detect a position of the breast prior to and during compression (Paragraph [0027]). In one embodiment, a position encoder 208 is used to measure the distance between the support platform and the compression paddle as the compression paddle is lowered (e.g. predetermined path) (Paragraphs [0027]-[0029]).
However, while St. Pierre’s encoder system enables the determination of the position of the tissue engaging surface along a predetermined path, St. Pierre does not expressly disclose using a wave detector and marker in the compression paddle to determine the position of the tissue engaging member along the predetermined path. Furthermore, while St. Pierre obtains diagnostic images, the system does not appear to disclose include an analyzer to analyze wave detector data to identify tissue with an elevated probability to comprise malignant cells from tissue not suspected to comprise malignant cells.
Hannemann teaches from within a similar field of endeavor with respect to tracking imaging components during a scan where position detection means may include a wave detector (e.g. ultrasonic measuring device, a camera such as a 3D camera, 2D camera, infrared camera or an encoder to detect the change in position of an imaging component (Paragraph [0066]). In one embodiment, signals from the sensors (e.g. cameras) can be transmitted to a computing unit to determine the position of an imaging component equipped with luminous marker reference points (Paragraph [0067]).
Accordingly, one skilled in the art would have been motivated to have modified the means to determine the position of the compression paddle along a predetermined path (e.g. encoder system) as described by St. Pierre with an ultrasonic measuring device and luminous marker and/or a camera and luminous marker arrangement as described by Hannemann in order determine the position of system components during use. Such a modification merely involves a simple substitution of one known positioning determining means for another to yield predictable results.
Regarding the analyzer, Fatemi teaches from within a similar field of endeavor with respect to systems and methods for diagnosing breast tissue where a wave detector (ultrasound probe; depicted in Figs. 3A-B and corresponding descriptions) and a data processing device connected to the wave detector for analyzing viscoelastic and/or strain of the tissue as a function of time to identify tissue with an elevated probability to comprise malignant cells in comparison with tissue that is not suspected to comprise malignant cells (Paragraphs [0004], [0007]-[0009], [0055] and [0066). Examiner notes that the identified lesion would read on the tissue with the elevated probability of malignant cells while the background tissue would read on tissue that is not suspected to comprise malignant cells in its broadest reasonable interpretation. Wang is cited herein to support the conclusion of obviousness to combine traditional mammography imaging systems (e.g. x-ray) with ultrasound and camera systems (Paragraphs [0017] and [0048]-[0049]).
Accordingly, one skilled in the art would have been motivated to have incorporated Fatemi’s ultrasound examination means into St. Pierre’s breast imaging system at various “sensor locations” in order to differentiate malignant tissue from background tissue using wave detector data and thus, improve patient diagnosis.
Regarding Claims 2-3, Fatemi discloses wherein the elasticity maps provide information on the stiffness of tissue in order to differentiate the lesion from background tissue (Paragraphs [0004] and [0055]).
As for Claim 4, Fatemi discloses wherein the processor is controlled by instructions stored in memory to perform data collection, processing and calculation steps (Paragraph [0066]).
As for Claim 5, Fatemi discloses wherein the processed data provides a spatial profile of a strain response as a function of time and/or viscoelastic retardation time that characterizes the object and includes several images during and at compression (Paragraphs [0003], [0008]-[0009], [0025] and [0044]) which would enable a longitudinal comparison of the data over time to derive the lesion and background tissue differentiation in its broadest reasonable interpretation.
With respect to Claims 9 and 16, the data collected and analyzed by the processing device relates to an “ultrasonic creep test” which involves acoustic radiation force or the aforementioned actuator (Fatami-Paragraphs [0026]-[0027] and [0062]) which would provide data relating to tissue disengaged from a load and engaged and loaded by the actuator to a predetermined “full load” in its broadest reasonable interpretation. Examiner notes that the aforementioned compression would relate to a “cycle” in its broadest reasonable interpretation.
As for Claim 10, the processing device is capable of estimating a contact area between the displacement actuator and the tissue during engagement of the tissue during compression as described above.
With respect to Claims 12-15 and 17, Fatemi discloses wherein the system includes load cells for simultaneous measurement and control of the desired force profile (Paragraph [0040]) and to create elasticity maps used to indicate tissue stiffness (Paragraph [0055]) in its broadest reasonable interpretation. In addition, St. Pierre discloses calculating a force applied to the breast until a threshold is met (Paragraphs [0031]-[0033]).
Regarding Claims 21-22, Examiner notes one skilled in the art would have been motivated to have repeated the measurements for each breast of the patient in order to effectively screen the patient for breast cancer. Any difference(s) may be visualized on the display of each image in its broadest reasonable interpretation.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over St. Pierre, Hannemann, Fatemi and Wang as applied to claim 1 above, and further in view of U.S. Publication No. 2020/0029934 to Sandrin.
As for Claim 11, St. Pierre, Hannemann, Fatemi and Wang discloses a system and method to screen breast tissue as described above. However, St. Pierre, Hannemann, Fatemi and Wang does not expressly disclose a capacitive measurement organ as claimed.
Sandrin teaches from within a similar field of endeavor with respect to elastography systems and methods (Abstract) wherein the system includes a capacitive force sensor in order to determine appropriate contact (Paragraphs [0057] and [0069]-[0076]).
Accordingly, one skilled in the art would have been motivated to have incorporated capacitive force measurement sensors into St. Pierre, Hannemann, Fatemi and Wang’s system and method described by Sandrin in order to determine an appropriate contact area for measurement.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over St. Pierre, Hannemann, Fatemi and Wang as applied to claim 18 above, and further in view of U.S. Publication No. 2021/0337885 to Connor.
As for Claims 19, St. Pierre, Hannemann, Fatemi and Wang discloses a system and method to screen breast tissue as described above. While St. Pierre uses sensors (e.g. cameras) to monitor conditions of the breast (e.g. changes in features, shapes or other characteristics or conditions of the breast (Paragraph [0025]), St. Pierre, Hannemann, Fatemi and Wang do not expressly disclose a CCD camera used to measure breast tissue properties.
Connor teaches from within a similar field of endeavor with respect to systems and methods used to detect abnormal breast tissue (Abstract) utilizing light emitters and light detectors (e.g. CCDs) used to receive light after passing through the breast to identify abnormal breast tissue (Paragraph [0362]).
Accordingly, one skilled in the art would have been motivated to have modified the system and method described by St. Pierre, Hannemann, Fatemi and Wang to also include light emitting and detecting means as described by Connor in order to analyze breast tissue properties. Such a modification merely involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
Claim(s) 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over St. Pierre, Hannemann, Fatemi and Wang as applied to claim 1 above, and further in view of U.S. Publication No. 2021/0390695 to Jie et al. “Jie”.
Regarding Claims 21-22, St. Pierre, Hannemann, Fatemi and Wang discloses a system and method to screen breast tissue as described above. While one skilled in the art would have been motivated to analyze both breasts for a complete diagnosis the art of record does not specify comparing left and right breast images.
Jie teaches from within a similar field of endeavor with respect to diagnostic imaging (Abstract; Paragraph [0026]) where images of both breasts can be compared for cancer diagnosis (Paragraph [0069]).
Accordingly, one skilled in the art would have been motivated to have imaged both breasts with the system and method described by St. Pierre, Hannemann, Fatemi and Wang for comparison as described by Jie in order to provide a complete patient diagnosis. Such a modification merely involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-5, 7 and 9-22 have been considered but are moot in view of the updated grounds of rejection necessitated by amendment. New 35 U.S.C. 112(b) rejections necessitated by amendment.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER L COOK whose telephone number is (571)270-7373. The examiner can normally be reached M-F approximately 8AM-5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Kozak can be reached at 571-270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTOPHER L COOK/ Primary Examiner, Art Unit 3797