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 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: receiving via a user interface, a user interface, a user identification of reference region or one or more regions of interest in claims 7, 9, 19 and 21 (see [0034] of specification as filed, input devices such as keyboards, mice touchscreens).
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 § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-5, 7, 9, 13-17, 19 and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Casciaro et al., US 20110257529 A1 ("Casciaro").
Regarding claims 1 and 13, Casciaro discloses a method and system for performing ultrasound motion tracking of pelvic floor structures ([abstract],[0002], [0007], Figs. 1 and 7-9) comprising:
an ultrasound detector (ultrasound probe 1 - Figs. 1, 7), a processor configured to execute machine readable instructions and a non-transitory computer readable medium having machine readable instructions to be executed by the processor are inherent features of control unit 13 (Figs. 1, 7, [0114], [0127] control unit 13 runs an algorithm-based program); to execute the following steps:
obtaining, by an ultrasound sensor, a plurality of ultrasound images of a region of tissue including a portion of a pelvis of a patient, the plurality of images including a first ultrasound image and a second ultrasound image, the second ultrasound image obtained at a different time than the first ultrasound image([0114] “… visual field 7 of ultrasound probe 1 includes … the whole endocervical canal 8” [0115] “Ultrasound probe 1 is connected to a control unit 13 that provides an ultrasound image 11 on a displaying unit 15, substantially in real time” [0128] “The algorithm carries out a monitoring phase, or automatic "tracking", of specific "pixel patterns" through a sequence of consecutive ultrasound images”, Fig. 8 @52 “reference echographic image” - i.e., first ultrasound image and Fig. 9 @62 “producing successive echographic image” - i.e., second ultrasound image);
identifying a reference region at a first position in the first ultrasound image, the reference region including a reference element; determining one or more regions of interest in the first ultrasound image, the one or more regions of interest including one or more target elements including a portion of a pelvic floor structure, the one or more regions of interest each having respective first positions defined relative to the reference region in the first ultrasound image ([0118-0120] and [0125] regarding anatomic reference points 28',28" of a reference region (i.e., region comprising endocervical canal - target element, is identified) that are needed for real-time calculation of the value of each parameters 25 that have been selected (54), see also [0043-0045] dilation of endocervical canal is a labor progress parameter and reference points being portions of the pubis);
determining, by the processor, (i) a second position of the reference region in the second image of the plurality of images, and (ii) a second position of the one or more regions of interest in the second ultrasound image; determining, by the processor, a change in position of the reference region from the first position of the reference region and the second position reference region; determining, by the processor, a change in position of the one or more regions of interest from (i) the first position of the one or more regions of interest, (ii) the second position of the one or more regions of interest, and (iii) the change in position of the reference region ([0128] “control unit 13 creates a region of interest (ROI) 21 about each reference point (61) Each ROI 21 has a prefixed size and comprises a set of pixels 23, which represents the pixel pattern 24 to be retrieved in the subsequent ultrasound images”, [0129] “… control unit 13 carries out then a scanning step of subsequent image 12 (63), defining a plurality of domains 36 that have the same shape and size of ROI 21 (64), in order to track a group of pixels which has features that match the features of pixel pattern 24 as initially defined by the algorithm”); and
determining, by the processor, from the change in position of the one or more regions of interest, movement of the portion of the pelvic floor structure ([0130] “The computing means calculate then the distance and the angles of inclination that are needed for quantitatively expressing parameters 25, and the corresponding values are displayed in section 17 of displaying unit 15”, [0031] “Parameter values 25 may furthermore be displayed as graphs 40 on a section 39 of graphic user interface 14 (68,69), in order to highlight their temporal evolution”, examiner note: temporal evolution indicate a movement of features associated with parameter values 25, note parameters 25 is a dilation 26 or length of the endocervical canal 8 [0119-0120], since endocervical canal is part of a pelvic floor structure, tracking temporal evolution of dilation 26 or length of the endocervical canal 8 indicate a movement of a portion of the pelvic floor structure).
Regarding claims 2 and 14, see [0128] “The algorithm carries out a monitoring phase, or automatic "tracking", of specific "pixel patterns" through a sequence of consecutive ultrasound images”.
Regarding claims 3-4 and 15-16, see [0043-0045] regarding region of interest selected on the edge of endocervical canal, on a fixed portion of parturient’ s body, in particular the pubis (a bone).
Regarding claim 5 and 17, see [0044-0045] and [0125] regarding monitoring dilation 26 of the endocervical canal which is associated with a distance between two regions of interest selected on the edge of the endocervical canal, the change in distance is associated with opening, closing or stretching of the pelvic floor structure.
Regarding claims 7, 9, 19 and 21, see [0125] regarding user selects, directly on reference ultrasound image 11 as displayed by screen 15, anatomic reference points via interactive graphical user interface 14 ([0115]).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 6, 8, 10-12, 18, 20 and 22-24 are rejected under 35 U.S.C. 103 as being unpatentable over Casciaro as applied to claim 1 above, and further in view of Singhal et al., US 20160045152 A1 ("Singhal").
Regarding claims 6, 8, 10-12 18, 20 and 22-24, as to claims 6 and 18, Casciaro does not explicitly disclose preprocessing of the at least one image of the first and second ultrasound image; as to claims 8, 10, 20 and 22, Casciaro does not explicitly disclose identification of the reference region or one or more region of interest is via image segmentation, and as to claims 11-12 and 23-24, Casciaro as discussed above teaches determining a first size and a second size of the one or more region of interest ([0119] dilation 26 of endocervical canal 8, [0125] monitoring dilation 26 of the endocervical canal and [0130] calculating a distance of parameters 25 (i.e., size of endocervical canal) and [0131] display of parameter values 25 temporal evolution indicates a change in size of the endocervical canal), as discussed above, the change in size of the endocervical canal is an indicate an opening or closing of the endocervical canal. Casciaro does not explicitly disclose determining a first and second orientation.
Singhal discloses automated identification of anatomical structures of interest that involves segmenting an ultrasound image to facilitate identification of region of interest and preprocessing the image via contrast enhancement ([0056-0059] and Fig. 5(s) @506), Singhal further teaches that region of interest resemble ridge-like structures [0061] and further teaches further processing of the contrast enhanced image to determine a measure of an isotropy indicative of ridge-like features with a determined orientation.
In view of the teachings of Singhal, at the time of filing the claimed invention, it would have been obvious to one of ordinary skill in the art to have modified Casciaro to include preprocessing of at least one image of the first and second ultrasound image via segmentation and contrast enhancement, and determination of a measure of isotropy with a determined orientation on the contrast enhanced image, for the added advantage of an automated process of identification of anatomical structures of interest.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BONIFACE N NGANGA whose telephone number is (571)270-7393. The examiner can normally be reached Mon. - Thurs. 5:30 am - 4:00 pm.
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/BONIFACE N NGANGA/Primary Examiner, Art Unit 3797