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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 07/20/2026 has been entered.
Response to Arguments
New claim objections necessitated by amendment.
Regarding 35 U.S.C. 101
Examiner notes that the previously set forth 101 rejection is withdrawn in view of the amendments to the claims.
Regarding 35 U.S.C. 112(a)
Examiner notes that the 112(a) rejections are withdrawn in view of the amendments to the claims. Specifically, examiner notes that a person having ordinary skill in the art would have recognized that a control unit on which computer programs are loaded which is configured to guide probes, detect and analyze ultrasound signals, etc. must be implemented by or on a general or special purpose computer. However, new 112(a) rejections are set forth in light of the amendments to the claims.
Regarding 35 U.S.C. 112(b)
Examiner notes that while some of the 112(b) rejections are withdrawn in view of the amendments to the claims, it is noted that the claims still include 112(b) clarity issues which were not addressed by the amendments to the claims or are introduced in light of the amendments to the claims. See below rejection for further detail. Examiner will address examiner’s remarks which remain relevant to the maintained rejections.
Applicant notes “applicant explains that the limitation refers to the same first and second arrays previously recited in claim 1” (REMARKS pg. 8-9). Examiner notes that the clarity issue does not arise as to whether the arrays are the same, but rather the transducers found in the arrays. In other words, the claim remains unclear as to whether the first and second arrays comprise the transducers recited previously AND an additional plurality of transducers that are positioned so that acquisitions are carried out on a plane… or if these are intending to refer to the same transducers recited previously. Examiner recommends amending the claims to refer back to the piezoelectric or CMUT transducers recited previously if they are intended to be the same and/or providing support for them to be different if they are intended to be different for enhanced clarity.
Applicant further notes “claim 1 recites that the raw radiofrequency ultrasound signal is the raw reflected ultrasound signal acquired by the first array before processing for B-mode image creation” (REMARKS pg. 14). Examiner notes that such an explanation does not make clear the relationship (if any) to the previously recited ultrasound signals which are also contained inside one of said suspect areas. The limitation remains unclear for failing to relate/distinguish the ultrasound signals.
Applicant argues “the amendment makes clear that the membrane and gel are components of the acoustic coupling materials” (Remarks pg. 18). Examiner respectfully disagrees in that the limitations appear to remain distinct/separate due to the introduction of each as apparaently separate elements. examiner recommends amending the claims to set forth that the acoustic coupling material comprises a flexible membrane, filled with a gel if they are intended to be the same. Such an amendment would merely replace “each probe” with “said acoustic coupling materials” for enhanced clarity.
Applicant remarks “claim 16 now depends from claim 12. This clarifies that the training and validation data sets are obtained by subdividing the already-defined reference data sets” (REMARKS pg. 35). Examiner notes that while claim 12 recites “reference”, there is no explicitly set forth “reference data sets” recited in claim 12, therefore, the limitation remains to be unclear as to what the reference data sets refers to.
Examiner recommends reviewing all of the claims for antecedent basis.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 recites “a imaginary line” however, should read –an imaginary line— for grammatical purposes.
Claim 1 recites “the average acoustic attenuation”, however, should read –an average acoustic attenuation— for purposes of proper antecedent basis.
Claim 1 recites “the ratio”, however, should read –a ratio— for purposes of proper antecedent basis.
Claim 1 recites “to calculate a diagnostic parameter”, however, should read –to calculate the diagnostic parameter—for purposes of proper antecedent basis.
Claim 9 recites “the presence or not of a breast cancer”, however, should read – the presence or absence of the breast cancer— for purposes of proper antecedent basis.
Claim 9 recites “morphological information as per”, however, should read –the morphological information as per— for purpose of proper antecedent basis.
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.
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:
The limitation “control unit” in claim 1 meets all 3 prongs of the analysis set forth in MPEP § 2181 (I). The limitation meets prong (A) because “units” is a generic placeholder for “means”. The limitation meets prong (B) because the generic placeholder (the “units”) is modified by functional language (“configured to guide said probes, detect and analyze ultrasound signals acquired by said probes, store raw radiofrequency ultrasound signals, process radiofrequency ultrasound signals to obtain B-mode ultrasound images, associate a relative position of acquisition with each detected signal and each image, and carry out a method for calculating a diagnostic parameter indicative of a presence or absence of breast cancer”). The limitation meets prong (C) because this claim element is not further modified by sufficient structure or material for performing the claimed function.
A review of the specification shows a computer/processor configured to perform steps as disclosed in at least pg. 22-25 appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation.
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 § 112(a)
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 1-9 and 11-17 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 limitation “the control device being configured by said computer programs, to guide said probes…. Associate a relative position of acquisition with each detected signal and each image”. These are understood to be a computer-implemented functional limitation which requires disclosure of the underlying algorithm(s) for obtaining the result in order to comply with the written description requirement. See MPEP § 2161.01(I). Examiner notes that while there is literal textual support for the limitations in the claims there is no implicit nor explicit disclosure of the steps/algorithm for performing such functions. In other words, the specification does not describe the nature of the guiding and associating nor any disclosure as to what is meant by such guiding/associating and how it is performed. Therefore, the claim contains subject matter which is not described in the specification in such a way as to reasonably convey to one with ordinary skill in the art that the inventor had possession of the claim invention at the time of filing.
Claim Rejections - 35 USC § 112(b)
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 1-9 and 11-17 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 recites the limitation “said first and second arrays arrays comprise each a plurality of piezoelectric or CMUT transducers, positioned so that acquisitions…”. It is unclear if the limitation is referring to the previously recited piezoelectric or CMUT transducers with a first nominal frequency/second nominal frequency or if these are different plurality of piezoelectric or CMUT transducers. In other words, it is unclear if the claims is attempting to further define the piezoelectric or CMUT transducers recited previously and their positioning or if the claim is attempting to set forth new piezoelectric or CMUT transducers which are positions in a certain manner. For examination purposes, it has been interpreted to mean any plurality of piezoelectric or CMUT transducers, however, clarification is required.
Claim 1 recites the limitation “the ultrasound imaging of one of said suspect tissue areas”. The limitation lacks sufficient antecedent basis and it is unclear which ultrasound imaging the claim is referring to since ultrasound imaging has not yet been previously recited and if the ultrasound imaging refers to the plurality of scans or if this are different ultrasound imaging. Furthermore “said suspect tissue areas” lacks sufficient antecedent basis as the claim previously recites “one or more suspect areas” therefore making it unclear if the limitation intends to further narrow the one or more suspect tissue areas to be plural suspect areas. For examination purposes, it has been interpreted to mean any ultrasound imaging of one suspect tissue area of said one or more suspect tissue areas, however, clarification is required.
Claim 1 recites the limitation “said suspect areas” in multiple instances. Each instance should be addressed in the same manner as explained above as said suspect areas is previously not recited. For examination purposes, each instance of “said suspect areas” is interpreted to mean “said one or more suspect tissue areas”, however, clarification is required.
Claim 1 recites the limitation “average grey value of the suspect area”. It is unclear which suspect area the limitation is referring to. For examination purposes, it has been interpreted to mean the one suspect tissue area of the one or more suspect tissue areas, however, clarification is required.
Claim 1 recites the limitation “one of said suspect areas” in multiple instances. Examiner notes that the limitation is unclear as to whether the limitation intends to refer to the same “one of said suspect areas” previously recited or if this is a different one of said suspect areas. In other words, it is unclear if the claim is attempting to define that different calculations are performed for different suspect areas or if the limitation intends to set forth the same one of said suspect areas. It appears applicant would intend to mean the same one suspect area, however, the claim is written in a way which introduces clarity issues. For examination purposes, it has been interpreted to mean the same one suspect tissue area, however, clarification is required.
Claim 1 recites the limitation “the outer region with respect to said suspect areas”. It is unclear if the outer region is the same as the surrounding region recited previously or if this is a different region. In other words, due to the language change it is unclear if the outer region is separate/distinct from the surrounding region included in the surrounding region, or the same as the surrounding region. For examination purposes, it has been interpreted that the outer region is the surrounding region, however, clarification is required.
Claim 1 recites the limitation “calculation of an acoustic propagation speed of the ultrasound signal relating to at least one propagation line of the ultrasound signal passing through one of said suspect areas and to at least one propagation line of the ultrasound signal not passing through any suspect area”. It is first unclear if the at least one propagation line is the same as, included in, or different from the propagation line recited previously (i.e. in step 220). For examination purposes, it has been interpreted that the at least one propagation line may be the same as or include the propagation line from step 220.
Claim 1 recites the limitation “calculation of a diagnostic parameter function of the comparison of at least one of the parameters calculated in steps 210 to 270 with the same parameters calculated with respect to suspect areas for which the presence of the pathology has been subsequently confirmed; suspect areas for which the presence of a breast cancer has been subsequently exclude by means of a biopsy or other equivalent reliable technique by means of a biopsy or other equivalent reliable technique; portions of tissue not interested by suspect areas”. It is unclear if the comparison of at least one of the parameters is comparted to multiple/all parameters or if comparison is to a corresponding parameter calculated in the same manner as the at least one of the parameters. It is further unclear if the comparison is made with respect to each of the suspect areas for which the presence of the pathology has been confirmed, suspect areas for which the presence of a breast cancer has been excluded, and portions of the tissue not interested by suspect areas or if the limitation refers to any one of the limitations as no “and” nor “or” is recited by the claim. It is further unclear if the suspect areas recited refer to any of the previously recited suspect areas or if these are different suspect areas. For examination purposes, it has been interpreted to mean that the at least one of the parameters is compared with a corresponding parameter calculated in a same manner as the at least one of the parameters, the corresponding parameter(s) are calculated with respect to one of the sepect areas (histologic examination), suspect areas (biopsy), or portions of tissue not interested by suspect areas, which are different from the one or more suspect areas previously recited, however, clarification is required.
Claim 6 recites the limitation “each probe comprises acoustic coupling materials configured to couple said probe with a portion of a breast skin, wherein each probe comprises a flexible membrane filled with a gel with the breast skin, comprising a flexible membrane filled with a gel”. The limitation is unclear as to whether the flexible membrane/gel is or is included in the acoustic coupling materials or if these are different elements. It appears that the flexible membrane and gel are the acoustic coupling materials, however, the claim appears to recite them as separate elements. For examination purposes, it has been interpreted that the acoustic coupling materials comprise a flexible membrane and a gel, however, clarification is required.
Claim 7 recites the limitation “said B-mode images acquired at step 110”. There is insufficient antecedent basis for the limitation in the claim as step 110 recites a second B-mode ultrasound image and does not recite images (plural). It is therefore unclear if the limitation intends to further narrow the second B-mode ultrasound image of step 110 to be multiple B-mode images or if the limitation intends to mean other B-mode images.
Claim 9 recites the limitation “calculation of a parameter”. It is unclear if the diagnostic parameter is the same as the diagnostic parameter recited in claim 1, if it is any of the other parameter used for calculating the diagnostic parameter as recited in claim 1 or if this is a different diagnostic parameter. For examination purposes, it has been interpreted to mean any diagnostic parameter, however, clarification is required.
Claim 9 recites the limitation “said suspect area”. There is insufficient antecedent basis for this limitation in the claim. It is unclear which of the one or more suspect areas the limitation is referring to. For examination purposes, it has been interpreted to mean any of the previously recited areas, however, clarification is required.
Claim 9 recites the limitation “information relating to a frequency spectrum of the raw reflected ultrasound signal stored at step 120) and associated to said suspect area”. It is unclear if this is included in the at least one frequency spectrum recited in claim 1 or if this is a different frequency spectrum. For examination purposes, it has been interpreted to mean any frequency spectrum, however, clarification is required.
Claim 11 recites the limitation “each of said suspect areas”. The limitation lacks sufficient antecedent basis, as previous claims recite one or more suspect areas. It is unclear which suspect areas the claim is referring to. For examination purposes, it has been interpreted to mean said one or more suspect tissue areas, however, clarification is required.
Claim 11 recites the limitation “the jth area”. There is insufficient antecedent basis for the limitation in the claim. It is therefore unclear if the jth area refers to one of the one or more suspect tissue areas or if this is a different area. For examination purposes, it has been interpreted to mean any of the one or more suspect areas, however, clarification is required.
Claim 11 recites the limitation “the suspect area”. There is insufficient antecedent basis for the limitation and it is unclear which suspect area the limitation is referring to. For examination purposes, it has been interpreted to mean any of the previously recited one or more suspect areas, however, clarification is required.
Claim 12 recites the limitation “selection of a plurality of segments of propagation of the ultrasound signal which either are: - contained inside suspect areas whose for which presence of breast cancer has been subsequently confirmed by means of histological examination; contained inside suspect areas for which the presence of a breast cancer has been subsequently excluded by means of a biopsy or other equivalent reliable technique and contained inside tissue located outside of suspect areas”. Claim 1 sets forth suspect areas which have been subsequently confirmed/excluded (by means of biopsy or other equivalent), however, it is unclear if these are the same suspect areas or claim 1 or different suspect areas. In other words, the claim does not refer to the suspect areas and it is further unclear since the suspect areas are recited here as being excluded by means of histological examination but are excluded by means of biopsy or other equivalent in claim 1. For examination purposes, it has been interpreted to mean either the same or different suspect areas, however, clarification is required.
Claim 14 recites the limitation “said diagnosis parameter is a classification of said one of said suspect areas as ‘tumoral’ or ‘not tumoral’”. It is unclear if the one of said suspect areas is the same as any of the previously recited one of said suspect areas or if this is a different one of said suspect areas. For examination purposes, it has been interpreted to mean the one suspect tissue areas of said one or more suspect tissue areas recited for the parameters of claim 1, however, clarification is required.
Claim 15 recites the limitation “said diagnosis parameter is a classification of a suspect area as tumoral or not tumoral”. It is unclear which suspect area the limitation is referring to. For examination purposes, it has been interpreted to mean the one suspect tissue area of the one or more suspect tissue areas, however, clarification is required.
Claim 15 recites the limitation “the jth area” in multiple instances. It is unclear if the jth area is any of the one or more suspect areas or if this is a different area. For examination purposes, it has been interpreted to mean the one suspect tissue area of the one or mores suspect tissue areas, however, clarification is required.
Claim 15 recites the limitation “in case one of said three correlation coefficients calculated at step 500 is greater than said first predetermined threshold, or in case the two lower correlation coefficients are both not lower than said predetermined threshold, the jth area is not classified. The limitation contradicts step 510 which sets forth that in case one of said three correlation coefficients is greater than a first predetermined threshold… classification of the jth area as the tumoral if said correlation coefficient great than a first predetermined threshold is the one with the tumoral reference spectrum. It is therefore unclear in which instances the jth area is not classified.
Claim 15 recites “the two lower correlation coefficients”. There is insufficient antecedent basis for the limitation in the claim. It is unclear what the two lower correlation coefficients refers to.
Claim 16 recites the limitation “subdivision of the reference sets available in a training data set and a validation data set”. There is insufficient antecedent basis for the reference sets. It is unclear what the reference sets refers to.
Claims 16 and 17 recite the limitation “the jth area”. It is unclear if the jth area is any of the one or more suspect areas or if this is a different area. For examination purposes, it has been interpreted to mean the one suspect tissue area of the one or mores suspect tissue areas, however, clarification is required.
Examiner’s Note
Examiner notes that claim 1 distinguishes over the prior art collectively, however, allowability is not determined at this time due to pending 112 issues. In this, case it is noted that Zhang and Masaki remain to the be the closest prior art, however, Zhang and Masaki fail to teach all of steps 210-280 in combination with the structure comprising two ultrasound probes having a first array and second array. Examiner notes that modifying Zhang and Masaki to include all of steps 210-280 would not have been obvious to a person having ordinary skill in the art before the effective filing date.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE L KLEIN whose telephone number is (571)270-5204. The examiner can normally be reached Mon-Fri 7:30-4.
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/BROOKE LYN KLEIN/Primary Examiner, Art Unit 3797
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